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

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT02347215
Collaborator
Duke Clinical Research Institute (Other), Massachusetts General Hospital (Other)
212
Enrollment
1
Location
1
Arm
64
Actual Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Quality of Life assessment
  • Procedure: Stress imaging
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
212 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Changes in Ischemia and Angina Over One Year Among ISCHEMIA Trial Screen Failures
Actual Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Seattle Angina Questionnaire (SAQ) score [baseline-one year comparison]

Secondary Outcome Measures

  1. Ischemia severity [baseline-one year comparison]

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

    comparison with SAQ score and with ischemia severity

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

    comparison with SAQ score and with atherosclerosis severity

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

    comparison with SAQ score and ischemia severity

  5. Major adverse cardiac events [one year]

    death, MI, stroke, cardiovascular hospitalizations/ER visits

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Medical Center and Bellevue Hospital Center New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • Duke Clinical Research Institute
  • Massachusetts General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT02347215
Other Study ID Numbers:
  • s11-00498
First Posted:
Jan 27, 2015
Last Update Posted:
Feb 17, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Angina Pectoris
Microvascular Angina
Ischemia

Study Results

No Results Posted as of Feb 17, 2020