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This study looked at the role of cardiac CT in improving risk factor control in those with diabetes.
This study examined whether doing a cardiac screening test, the cardiac CT, would result in patients paying more attention to controlling their risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac CT | Experimental | Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries. |
|
| Usual Care | Active Comparator | Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac CT | Diagnostic Test | A cardiac CT involves a non-invasive test of the coronary arteries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic BP Pressure | After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure. | Five year follow up |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Treatment by PCP | Medication dose change or medication start/stop | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaista Malik, MD, PhD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
Deidentified data will be available
Data is now available
We will need written request to share data
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac CT | Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries. Cardiac CT: A cardiac CT involves a non-invasive test of the coronary arteries. |
| FG001 | Usual Care | Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician Usual medical care: Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiac CT Group | Asymptomatic patients with Type II DM who received cardiac CT screening test |
| BG001 | Usual Care Group | Asymptomatic patients with Type II DM who received usual care |
| 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 | Systolic BP Pressure | After randomization to either obtain cardiac CT or usual care, patients will be followed for 5 years (with assessment of outcomes at every 6 months) to see any difference in control of systolic blood pressure. The outcome with be assessed as a continuous measure. | Posted | Mean | Standard Deviation | mm Hg | Five year follow up |
|
5 years
No adverse events
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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 | Cardiac CT | Patients randomized to cardiac CT will obtain a non-invasive assessment of their coronary arteries. Cardiac CT: A cardiac CT involves a non-invasive test of the coronary arteries. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashwini Erande, Clinical Coordinator | University of California, Irvine | 714 456 7025 | aerande@uci.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001786 | Blood Glucose |
| ID | Term |
|---|---|
| D005947 | Glucose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Usual medical care | Behavioral | Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Change in Treatment by PCP | Medication dose change or medication start/stop | Not Posted | 2 years | Participants |
| Other Pre-specified | Change in Treatment by PCP | Medication dose change or medication start/stop | Not Posted | 2 years | Participants |
| 0 |
| 92 |
| 0 |
| 92 |
| EG001 | Usual Care | Patients randomized to usual care will be assigned to continuing usual medical care with their primary care physician Usual medical care: Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion. | 0 | 93 | 0 | 93 |
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| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| Carbohydrates |