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

February 13, 2020 updated by: NYU Langone Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Medical Center and Bellevue Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Massachusetts General Hospital
Duke Clinical Research Institute

Investigators

  • Principal Investigator: Judith Hochman, MD, New York Langone Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 26, 2015

First Posted (Estimate)

January 27, 2015

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s11-00498

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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