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

Not Applicable

Completed

• Conditions: Angina Pectoris; Microvascular Angina
• Interventions: Other: Quality of Life assessment; Procedure: Stress imaging

• Registration Number: NCT02347215
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-26
• Study First Posted: 2015-01-27
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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

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Exclusion Criteria

• Inability to comply with protocol
• Prior PCI or CABG

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Quality of Life assessment	All patients undergo quality of life assessment at 2-3 time points and stress imaging at two time points
All patients	Stress imaging	All patients undergo quality of life assessment at 2-3 time points and stress imaging at two time points

Primary Outcome Measures

Name	Time	Method
Seattle Angina Questionnaire (SAQ) score	baseline-one year comparison

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYU Medical Center and Bellevue Hospital Center; 🇺🇸 New York, New York, United States