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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: New York University School of Medicine

Current Primary Outcome: Seattle Angina Questionnaire (SAQ) score [ Time Frame: baseline-one year comparison ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ischemia severity [ Time Frame: 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
  • Ischemia severity (comparison with SAQ score and with ischemia severity) [ Time Frame: baseline ]
    comparison with SAQ score and with atherosclerosis severity
  • Medical therapy used for angina (comparison with SAQ score and ischemia severity) [ Time Frame: one year ]
    comparison with SAQ score and ischemia severity
  • Major adverse cardiac events [ Time Frame: one year ]
    death, MI, stroke, heart failure, cardiovascular hospitalizations


Original Secondary Outcome: Same as current

Information By: New York University School of Medicine

Dates:
Date Received: January 14, 2015
Date Started: August 2014
Date Completion: May 2018
Last Updated: December 2, 2016
Last Verified: December 2016