Changes in Ischemia and Angina Over 1 Year Among ISCHEMIA Trial Screen Failures With no Obstructive CAD on Coronary CT Angiography

Study Overview
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Brief Summary
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Serial assessment of angina status and ischemia on stress echo over one year among patients with moderate ischemia on stress imaging and non-obstructive CAD on coronary CT angiography.

Detailed Description
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Some people with chest pain are found to have open arteries on angiograms instead of blocked arteries and many, but not all, of these people have abnormal stress tests or other tests showing there is not enough blood flow to the heart. Prior research has not made clear whether chest pain in such patients is due to heart disease or something else, in part because no one has found out whether chest pain and stress test results change in the same direction over time. This study will use two measurements of chest pain and two stress tests, one year apart, to find out if chest pain and abnormal stress tests are both caused by the same problem: not enough blood flow to the heart.The association between angina, ischemia and atherosclerosis severity at baseline will be examined, as will medication effects.

Official Title
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Changes in Ischemia and Angina Over One Year Among ISCHEMIA Trial Screen Failures

Conditions
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Microvascular Angina, Angina Pectoris

Intervention / Treatment
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* Other: Quality of Life assessment
* Procedure: Stress imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled but not randomized in ISCHEMIA trial Stress echocardiography used for enrollment* No obstructive CAD on study coronary CT angiography (defined as no ≥50% stenosis in a major epicardial vessel) Ischemic symptoms (chest pain or other potential ischemic equivalent). Participant is willing to give written informed consent Age ≥ 21 years Exclusion Criteria: Inability to comply with protocol Prior PCI or CABG

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All patients<br>All patients undergo quality of life assessment at 2-3 time points and stress imaging at two time points | Other: Quality of Life assessment<br>* Seattle Angina Questionnaire and other questionnaires.<br>Procedure: Stress imaging<br>* Stress imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seattle Angina Questionnaire (SAQ) score |  | baseline-one year comparison | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia severity |  | baseline-one year comparison | 
| Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity) | comparison with SAQ score and with ischemia severity | baseline | 
| Ischemia severity (comparison with SAQ score and with ischemia severity) | comparison with SAQ score and with atherosclerosis severity | baseline | 
| Medical therapy used for angina (comparison with SAQ score and ischemia severity) | comparison with SAQ score and ischemia severity | one year | 
| Major adverse cardiac events | death, MI, stroke, cardiovascular hospitalizations/ER visits | one year |