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| Name | Class |
|---|---|
| Saint Luke's Health System | OTHER |
| Saint Luke's Cardiovascular Consultants | OTHER |
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The purpose of this study is to measure the changes in cardiac function during a Lexiscan pharmacologic stress test using cardiac magnetic resonance imaging test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regadenoson | Other | Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regadenoson | Drug | Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RADIAL STRAIN | A measurement of the relative displacement between myocardial points between end-diastole and end-systole along a common ray extending from the center of the left ventricular (LV) cavity (analogous to myocardial thickening). A normal radial strain is indicated by a positive decimal value and can be understood as the percentage change in wall thickness of a myocardial segment. A POSITIVE change in radial strain indicates an increase in wall thickening. Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless. | Day 1 |
| CIRCUMFERENTIAL STRAIN | A measurement of the relative displacement of myocardial points directed along the circumference of the ventricular wall at a given radial distance from the left ventricular (LV) cavity center (e.g. midline). A normal circumferential strain is indicated by a negative decimal value and can be understood as the percentage shortening along the ventricular wall with a greater negative value indicating greater ventricular shortening along the circumference. A positive change in strain would therefore be interpreted as a decrease in circumferential shortening. Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain | For each subject, the 16-segments were visually assessed along the short-axis plane for the presence of LGE. These images were collected post regadenoson stress recovery using an inversion-recovery prepared, fast gradient echo sequence and a delay of at least 8 minutes after administration of a single dose of gadobenate dimeglumine. The presence of LGE within a segment is a separate classification of segment type. The segment classifications in the other outcomes are determined from the prior positron-emission-tomography (PET) examination where the LGE determination is based solely on cardiac magnetic resonance (CMR) imaging collected data. The measurement was performed to determine if the presence of LGE within a particular segment affect the resulting strain? |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy M Bateman, MD | Aspire Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Luke's Health System | Kansas City | Missouri | 64111 | United States |
Cardiac Magnetic Resonance (CMR) imaging was performed in the same order for all subjects with rest imaging preceding regadenoson stress imaging.
The same prescription for tagged CMR slice locations (basal, mid, and apical) were used at both rest and stress.
All subjects were recruited from two groups: a population with coronary artery disease (CAD) of those with low-likelihood-CAD (Control). The myocardial segment perfusion and wall motion scores from the prior clinical positron-emission-tomography (PET) were used to classify segments as one of the following: CONTROL, CAD_REMOTE, CAD_REVERSIBLE.
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| ID | Title | Description |
|---|---|---|
| FG000 | CONTROL | Myocardial strain imaging was performed for all subjects in a similar order. Rest-tag imaging was performed first, then Stress-tag imaging was performed at maximal heart rate following administration of the regadenoson dose. Strain values were then calculated for each of 16-segments for each subject. Segments are classified based on myocardial perfusion imaging scores. A Control subject is an individual from a population of low-likelihood CAD exhibiting both normal perfusion score and normal wall motion score rest-to-stress as indicated on a clinically indicated PET. |
| FG001 | Coronary Artery Disease | Myocardial strain imaging was performed for all subjects in a similar order. Rest-tag imaging was performed first, then Stress-tag imaging was performed at maximal heart rate following administration of the regadenoson dose. Strain values were then calculated for each of 16-segments for each subject. Segments are classified based on myocardial perfusion imaging scores. A Coronary Artery Disease (CAD) subject is an individual from a population with CAD exhibiting both normal perfusion and normal wall motion scores (rest-to-stress) on a prior clinically indicated PET. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CONTROL | Myocardial strain imaging was performed for all subjects in a similar order. Rest-tag imaging was performed first, then Stress-tag imaging was performed at maximal heart rate following administration of the regadenoson dose. Strain values were then calculated for each of 16-segments for each subject. Segments are classified based on myocardial perfusion imaging scores. A control subject is an individual from a low-likelihood CAD population with a prior clinically indicated PET with perfusion and wall motion scores (rest-to-stress). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | RADIAL STRAIN | A measurement of the relative displacement between myocardial points between end-diastole and end-systole along a common ray extending from the center of the left ventricular (LV) cavity (analogous to myocardial thickening). A normal radial strain is indicated by a positive decimal value and can be understood as the percentage change in wall thickness of a myocardial segment. A POSITIVE change in radial strain indicates an increase in wall thickening. Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless. | Myocardial segments classified according to subject groups and myocardial perfusion and wall motion scores on prior positron-emission-tomography (PET). | Posted | Mean | Standard Deviation | unitless (strain) | Day 1 | myocardial segments | myocardial segments |
|
Day 1
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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 | Regadenoson | Regadenoson is a single-use, pre-filled syringe containing 0.4 mg/5 mL of regadenoson. Regadenoson: Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging. Strain imaging was performed on ALL subjects in the same order with resting strain preceding regadenoson stress strain. Myocardial segments were classified based on prior clinical positron-emission-tomography (PET) results so that segmental strain response to regadenoson could be observed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnea | General disorders | Systematic Assessment |
Reported strain is not adjusted for myocardial mass.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Soltys, PhD | Cardiovascular Imaging Technologies, LLC | 816-531-2842 | 103 | jsoltys@cvit.com |
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| 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 | Feb 27, 2017 | Jun 27, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C430916 | regadenoson |
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| Day 1 |
| Adverse Events | Adverse events were monitored and recorded on a specific Adverse Event (AE) log. | Day 1 |
| Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain | The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain | Day 1 |
| BG001 | Coronary Artery Disease | Myocardial strain imaging was performed for all subjects in a similar order. Rest-tag imaging was performed first, then Stress-tag imaging was performed at maximal heart rate following administration of the regadenoson dose. Strain values were then calculated for each of 16-segments for each subject. Segments are classified based on myocardial perfusion imaging scores. A Coronary artery disease subject is an individual from a CAD population with a prior clinically indicated PET with perfusion and wall motion scores (rest-to-stress). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | CAD_REMOTE | A myocardial segment from an individual from a population with CAD exhibiting normal perfusion scores and normal wall motion scores (rest-to-stress) on a prior clinically indicated PET. |
| OG002 | CAD_REVERSIBLE | A myocardial segment from an individual from a population with CAD exhibiting a change in perfusion scores and a change in wall motion scores (rest-to-stress) on a prior clinically indicated PET. |
|
|
|
| Primary | CIRCUMFERENTIAL STRAIN | A measurement of the relative displacement of myocardial points directed along the circumference of the ventricular wall at a given radial distance from the left ventricular (LV) cavity center (e.g. midline). A normal circumferential strain is indicated by a negative decimal value and can be understood as the percentage shortening along the ventricular wall with a greater negative value indicating greater ventricular shortening along the circumference. A positive change in strain would therefore be interpreted as a decrease in circumferential shortening. Because strain is a measurement in change in length (distance) divided by an original length (distance) it is considered unitless. | Myocardial segments from the population groups according to the AHA 16-segment model and classified according to PET perfusion and wall motion scores. | Posted | Mean | Standard Deviation | strain (unitless) | Day 1 | myocardial segments | myocardial segments |
|
|
|
|
| Secondary | Late Gadolinium Enhancement (LGE) and RADIAL Myocardial Strain | For each subject, the 16-segments were visually assessed along the short-axis plane for the presence of LGE. These images were collected post regadenoson stress recovery using an inversion-recovery prepared, fast gradient echo sequence and a delay of at least 8 minutes after administration of a single dose of gadobenate dimeglumine. The presence of LGE within a segment is a separate classification of segment type. The segment classifications in the other outcomes are determined from the prior positron-emission-tomography (PET) examination where the LGE determination is based solely on cardiac magnetic resonance (CMR) imaging collected data. The measurement was performed to determine if the presence of LGE within a particular segment affect the resulting strain? | LGE imaging by CMR was acquired only in subjects meeting GFR restrictions. | Posted | Mean | Standard Deviation | strain (unitless) | Day 1 | Myocardial Segments | Myocardial Segments |
|
|
|
|
| Secondary | Adverse Events | Adverse events were monitored and recorded on a specific Adverse Event (AE) log. | Count of Adverse Events not clinically expect and reportable to IRB. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Late Gadolinium Enhancement and CIRCUMFERENTIAL Myocardial Strain | The Effects of the presence of LGE on CIRCUMFERENTIAL myocardial Strain | LGE as determined by CMR imaging using the AHA 16 segment model. | Posted | Mean | Standard Deviation | strain (unitless) | Day 1 | Myocardial Segments | Myocardial Segments |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 29 |
| 36 |
| Chest Discomfort | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Flushing | General disorders | Systematic Assessment |
|
| Abdominal: ache/discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Numbness: Jaw/shoulder | General disorders | Systematic Assessment |
|
| Anxiety | General disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
|
| REST-to-STRESS CHANGE |
|
| 0.003 |
non-adjusted |
| Superiority |
| Rest VS Regadenoson Stress | paired, t-test | 0.390 | Superiority | non-adjusted |
| REST | t-test, 2 sided | <0.000 | Superiority | non-adjusted |
| REST | t-test, 2 sided | <0.000 | Superiority | non-adjusted |
| REST | t-test, 2 sided | 0.022 | Superiority | non-adjusted |
| Regadenoson STRESS | t-test, 2 sided | 0.001 | non-adjusted | Superiority |
| Regadenoson STRESS | t-test, 2 sided | <0.000 | non-adjusted | Superiority |
| Regadenoson STRESS | t-test, 2 sided | 0.006 | non-adjusted | Superiority |
| REST-TO-STRESS Change | t-test, 2 sided | non-adjusted | <0.000 | Superiority |
| REST-TO-STRESS Changes | t-test, 2 sided | non-adjusted | 0.058 | Superiority |
| REST-TO-STRESS Change | t-test, 2 sided | non-adjusted | 0.310 | Superiority |
|
| REST-to_STRESS |
|
non adjusted
| 0.002 |
| Superiority |
| REST vs STRESS | paired, t-test | non adjusted | 0.721 | Superiority |
| REST | t-test, 2 sided | non adjusted | 0.797 | Superiority |
| REST | t-test, 2 sided | non adjusted | 0.474 | Superiority |
| t-test, 2 sided | non adjusted | 0.537 | Superiority |
| Regadenoson STRESS | t-test, 2 sided | non adjusted | 0.717 | Superiority |
| Regadenoson STRESS | t-test, 2 sided | non adjusted | 0.041 | Superiority |
| Regadenoson STRESS | t-test, 2 sided | non adjusted | 0.050 | Superiority |
| REST-to-STRESS Change | t-test, 2 sided | 0.908 | non adjusted | Superiority |
| t-test, 2 sided | non adjusted | 0.233 | Superiority |
| REST-to-STRESS Change | t-test, 2 sided | non adjusted | 0.187 | Superiority |
|
| REST-to-STRESS |
|
non adjusted
| 0.006 |
| Superiority |
| REST vs STRESS | paired, t-test | non adjusted | 0.428 | Superiority |
| REST | t-test, 2 sided | non adjusted | <0.000 | Superiority |
| REST | t-test, 2 sided | non adjusted | <0.000 | Superiority |
| REST | t-test, 2 sided | non adjusted | 0.006 | Superiority |
| Regadenoson STRESS | t-test, 2 sided | non adjusted | 0.002 | Superiority |
| Regadenoson STRESS | t-test, 2 sided | non adjusted | <0.000 | Superiority |
| Regadenoson STRESS | t-test, 2 sided | non adjusted | 0.004 | Superiority |
| REST-to-STRESS Change | t-test, 2 sided | non adjusted | <0.000 | Superiority |
| REST-to-STRESS Change | t-test, 2 sided | non adjusted | 0.172 | Superiority |
| REST-to-STRESS Change | t-test, 2 sided | non adjusted | 0.957 | Superiority |