Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL132358-01A1 | U.S. NIH Grant/Contract | View source |
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Study funding ended prior to planned study accrual and prior to planned completion of all enrolled subjects.
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Both, CT scans and VQ scans, are used by doctors to look for pulmonary embolism. The most common reason to order a VQ scan is to avoid the IV dye. The IV dye used for CT scans can cause kidney problems in some patients, called contrast-induced nephropathy or "CIN." This is a kidney problem that usually does not make patients feel any differently or change how they urinate. Most of the time, it can only be found by testing blood several days later. This kind of kidney problem can be very mild and some patients will never have any symptoms, rarely these problems can be severe. Some patients can also have similar kidney problems for many other reasons (reactions to medications, blood pressure problems, etc.) and can even happen in patients that do not get IV dye. That is why doctors are not sure exactly who will have these problems or if using a test that does not use IV dye can prevent this kidney problem. The VQ scan uses a different medication through the IV that is not IV dye and has not been linked to kidney problems. The purpose of this study is to learn if using the test that does not use IV dye (the "VQ scan") instead of a CT scan in some patients can help to prevent kidney problems.
Before the study begins, research personnel will do the following to be sure that patients can be in the study:
If the patient is eligible to continue in the study, the following will also happen at the initial day of enrollment:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized to V/Q | Active Comparator | Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control) |
|
| Randomized to CT | Active Comparator | Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V/Q imaging | Diagnostic Test | Standard of care |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants Who Developed AKI at 7 Days | Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline. | 7 days post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Count of Participants Who Developed AKI at 30 Day Follow-up | Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline | 30 days after enrollment |
| Count of Participants Who Developed AKI at 1 Year Follow-up |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health | Indianapolis | Indiana | 46202 | United States | ||
| Corewell Health |
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized to V/Q | Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control) V/Q imaging: Standard of care |
| FG001 | Randomized to CT | Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media) Computed tomography scan: Standard of care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Randomized to V/Q | Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control) V/Q imaging: Standard of care |
| BG001 | Randomized to CT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count of Participants Who Developed AKI at 7 Days | Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline. | Posted | Count of Participants | Participants | 7 days post enrollment |
|
Adverse event data were collected at 24 hours, 2-7 days, 30 days, and 1 year after enrollment.
The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definition.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Randomized to V/Q | patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to VQ imaging (unexposed control) V/Q imaging: Standard of care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Emergency Department Visit | General disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Pettit | Indiana University | 317-278-7082 | klpettit@iu.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 2, 2019 | Sep 20, 2019 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000076665 | Ventilation-Perfusion Scan |
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Computed tomography scan | Diagnostic Test | Standard of care |
|
|
Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline
| 1 year after enrollment |
| Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 7 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 7 days of enrollment |
| Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 30 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 30 days of enrollment |
| Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 1 Year | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 1 year of enrollment |
| Count of Participants With an AKI Risk Score <2, That Developed AKI Within 7 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 7 days of enrollment |
| Count of Participants With an AKI Risk Score <2, That Developed AKI Within 30 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 30 days of enrollment |
| Count of Participants With an AKI Risk Score <2, That Developed AKI Within 1 Year | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 1 year of enrollment |
| Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 7 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 7 days of enrollment |
| Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 30 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 30 days of enrollment |
| Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 1 Year | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 1 year of enrollment |
| Count of Participants With an AKI Risk Score <2 and Negative Biomarkers, That Developed AKI Within 7 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 7 days of enrollment |
| Count of Participants With an AKI Risk Score <2 and Negative Biomarkers, That Developed AKI Within 30 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 30 days of enrollment |
| Count of Participants With an AKI Risk Score <2 and Negative Biomarkers,That Developed AKI Within 1 Year | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Within 1 year of enrollment |
| Count of Participants Who Developed AKI Within 7 Days and Had a Health Outcome | Count of participants who developed AKI within 7 days and had a health outcome. Health outcomes are defined as death, severe kidney injury (AKIN3), or the need for dialysis. | Within 7 days of enrollment |
| Count of Participants Who Did Not Develop AKI Within 7 Days and Had a Health Outcome | Count of participants who did not develop AKI within 7 days and had a health outcome | Within 7 days of enrollment |
| Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging at Enrollment | Count of participants with Venous Thromboembolism (VTE) identified on imaging at enrollment | At enrollment |
| Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 7 Days of Enrollment | Count of participants with Venous Thromboembolism (VTE) identified on imaging within 7 days of enrollment | Within 7 days of enrollment |
| Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 30 Days of Enrollment | Count of participants with Venous Thromboembolism (VTE) identified on imaging within 30 days of enrollment | Within 30 days of enrollment |
| Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 1 Year of Enrollment | Count of participants with Venous Thromboembolism (VTE) identified on imaging within 1 year of enrollment | Within 1 year of enrollment |
| Count of Participants With Venous Thromboembolism (VTE) That Had a Health Outcome | Count of participants with Venous Thromboembolism (VTE) that had a health outcome | Within 1 year of enrollment |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| Baylor, Scott & White Health | Dallas | Texas | 75246 | United States |
| Intermountain Healthcare | Murray | Utah | 84107 | United States |
| University of Utah | Salt Lake City | Utah | 84132 | United States |
Patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media)
Computed tomography scan: Standard of care
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Count of Participants Who Developed AKI at 30 Day Follow-up | Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline | Posted | Count of Participants | Participants | 30 days after enrollment |
|
|
|
| Secondary | Count of Participants Who Developed AKI at 1 Year Follow-up | Count of participants with a creatinine increase ≥ 0.3 mg/dL or 1.5 times baseline | Posted | Count of Participants | Participants | 1 year after enrollment |
|
|
|
| Secondary | Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 7 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Analysis restricted to participants with an AKI Score ≥2 and those who were followed for the designated duration. There were 56 participants with an AKI Score ≥2 in the V/Q arm and 63 in the CT arm. | Posted | Count of Participants | Participants | Within 7 days of enrollment |
|
|
|
| Secondary | Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 30 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Analysis restricted to participants with an AKI Score ≥2 and those who were followed for the designated duration. There were 56 participants with an AKI Score ≥2 in the V/Q arm and 63 in the CT arm. | Posted | Count of Participants | Participants | Within 30 days of enrollment |
|
|
|
| Secondary | Count of Participants With an AKI Risk Score ≥2, That Developed AKI Within 1 Year | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Analysis restricted to participants with an AKI Score ≥2 and those who were followed for the designated duration. There were 46 participants with an AKI Score ≥2 in the V/Q arm and 49 in the CT arm. | Posted | Count of Participants | Participants | Within 1 year of enrollment |
|
|
|
| Secondary | Count of Participants With an AKI Risk Score <2, That Developed AKI Within 7 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Analysis restricted to participants with an AKI Score<2 and those who were followed for the designated duration. There were 17 participants with an AKI Score <2 in the V/Q arm and 117 in the CT arm. | Posted | Count of Participants | Participants | Within 7 days of enrollment |
|
|
|
| Secondary | Count of Participants With an AKI Risk Score <2, That Developed AKI Within 30 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Analysis restricted to participants with an AKI Score<2 and those who were followed for the designated duration. There were 17 participants with an AKI Score <2 in the V/Q arm and 117 in the CT arm. | Posted | Count of Participants | Participants | Within 30 days of enrollment |
|
|
|
| Secondary | Count of Participants With an AKI Risk Score <2, That Developed AKI Within 1 Year | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Analysis restricted to participants with an AKI Score<2 and those who were followed for the designated duration. There were 14 participants with an AKI Score <2 in the V/Q arm and 112 in the CT arm. | Posted | Count of Participants | Participants | Within 1 year of enrollment |
|
|
|
| Secondary | Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 7 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure. | Posted | Within 7 days of enrollment |
|
|
| Secondary | Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 30 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure. | Posted | Within 30 days of enrollment |
|
|
| Secondary | Count of Participants With an AKI Risk Score ≥2 or Positive Biomarkers, That Developed AKI Within 1 Year | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure. | Posted | Within 1 year of enrollment |
|
|
| Secondary | Count of Participants With an AKI Risk Score <2 and Negative Biomarkers, That Developed AKI Within 7 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure. | Posted | Within 7 days of enrollment |
|
|
| Secondary | Count of Participants With an AKI Risk Score <2 and Negative Biomarkers, That Developed AKI Within 30 Days | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure. | Posted | Within 30 days of enrollment |
|
|
| Secondary | Count of Participants With an AKI Risk Score <2 and Negative Biomarkers,That Developed AKI Within 1 Year | Among patients enrolled who had an AKI risk score evaluated and followed for the outcome of acute kidney injury. AKI risk Score: age ≥50 years (1 point), HIV (1 point), coronary artery disease (1 point), diastolic hypertension ≥100 mmHg (1 point), and glycosuria ≥250 mg/dL (2 points). Preliminary data indicated that a higher risk score was associated with a higher rate of kidney injury, but this was an unvalidated score. The lowest score possible is 0 and the highest score possible is 6. | Biomarkers not assessed. Samples were not available to test due to a shipping error during which some samples were thawed and a -80 degree freezer failure. | Posted | Within 1 year of enrollment |
|
|
| Secondary | Count of Participants Who Developed AKI Within 7 Days and Had a Health Outcome | Count of participants who developed AKI within 7 days and had a health outcome. Health outcomes are defined as death, severe kidney injury (AKIN3), or the need for dialysis. | Analysis restricted to participants who developed AKI within 7 days. There were 6 participants in the V/Q arm and 6 in the CT arm. | Posted | Count of Participants | Participants | Within 7 days of enrollment |
|
|
|
| Secondary | Count of Participants Who Did Not Develop AKI Within 7 Days and Had a Health Outcome | Count of participants who did not develop AKI within 7 days and had a health outcome | Analysis restricted to participants who did not develop AKI within 7 days. There were 67 participants in the V/Q arm and 174 in the CT arm. | Posted | Count of Participants | Participants | Within 7 days of enrollment |
|
|
|
| Secondary | Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging at Enrollment | Count of participants with Venous Thromboembolism (VTE) identified on imaging at enrollment | Posted | Count of Participants | Participants | At enrollment |
|
|
|
| Secondary | Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 7 Days of Enrollment | Count of participants with Venous Thromboembolism (VTE) identified on imaging within 7 days of enrollment | Posted | Count of Participants | Participants | Within 7 days of enrollment |
|
|
|
| Secondary | Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 30 Days of Enrollment | Count of participants with Venous Thromboembolism (VTE) identified on imaging within 30 days of enrollment | Posted | Count of Participants | Participants | Within 30 days of enrollment |
|
|
|
| Secondary | Count of Participants With Venous Thromboembolism (VTE) Identified on Imaging Within 1 Year of Enrollment | Count of participants with Venous Thromboembolism (VTE) identified on imaging within 1 year of enrollment | Posted | Count of Participants | Participants | Within 1 year of enrollment |
|
|
|
| Secondary | Count of Participants With Venous Thromboembolism (VTE) That Had a Health Outcome | Count of participants with Venous Thromboembolism (VTE) that had a health outcome | Analysis restricted to participants with VTE identified on imaging within 1 year on enrollment. There were 0 participants in the VQ arm and 0 participants in the CT arm. | Posted | Within 1 year of enrollment |
|
|
| 4 |
| 73 |
| 30 |
| 73 |
| 11 |
| 73 |
| EG001 | Randomized to CT | patients with > 25% estimated risk of CIN (CINRisk Score ≥ 2), randomized to CT (exposure to iodinated contrast media) Computed tomography scan: Standard of care | 7 | 180 | 43 | 180 | 11 | 180 |
| Death | General disorders | Systematic Assessment |
|
| AKI | Renal and urinary disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anaphylaxis type reaction | General disorders | Systematic Assessment |
|
| NSTEMI | Cardiac disorders | Systematic Assessment |
|
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Weakness/dizziness | General disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003947 |
| Diagnostic Techniques, Radioisotope |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D007090 | Image Interpretation, Computer-Assisted |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |