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OpenTrials
Completed

NCT Number: NCT02347215

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

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.

Completed

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Key information

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Medical Center and Bellevue Hospital Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of Life Assessment

Other

Seattle Angina Questionnaire and other questionnaires.

Stress imaging

Procedure

Stress imaging

Primary outcomes

  1. Seattle Angina Questionnaire (SAQ) score

    Time frame: baseline-one year comparison

Secondary outcomes

  1. Ischemia severity

    Time frame: baseline-one year comparison

  2. Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)

    Time frame: baseline

    comparison with SAQ score and with ischemia severity

  3. Ischemia severity (comparison with SAQ score and with ischemia severity)

    Time frame: baseline

    comparison with SAQ score and with atherosclerosis severity

  4. Medical therapy used for angina (comparison with SAQ score and ischemia severity)

    Time frame: one year

    comparison with SAQ score and ischemia severity

  5. Major adverse cardiac events

    Time frame: one year

    death, MI, stroke, cardiovascular hospitalizations/ER visits

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Duke Clinical Research Institute
  • Massachusetts General Hospital

Registry information

Official study title

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

Acronym: CIAO

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jan 27, 2015
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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