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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2019-12-31

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.

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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.

Conditions

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Microvascular Angina Angina Pectoris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All patients

All patients undergo quality of life assessment at 2-3 time points and stress imaging at two time points

Group Type OTHER

Quality of Life assessment

Intervention Type OTHER

Seattle Angina Questionnaire and other questionnaires.

Stress imaging

Intervention Type PROCEDURE

Stress imaging

Interventions

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Quality of Life assessment

Seattle Angina Questionnaire and other questionnaires.

Intervention Type OTHER

Stress imaging

Intervention Type PROCEDURE

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