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

Angina Pectoris Clinical Trial

— CIAO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347215
• Other study ID #: s11-00498
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: December 2019

Study information

• Verified date: February 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Ischemia
• Microvascular Angina

Intervention

Other:
• Quality of Life assessment
Seattle Angina Questionnaire and other questionnaires.

Procedure:
• Stress imaging
Stress imaging

Locations

Country	Name	City	State
United States	NYU Medical Center and Bellevue Hospital Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	Duke Clinical Research Institute, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seattle Angina Questionnaire (SAQ) score		baseline-one year comparison
Secondary	Ischemia severity		baseline-one year comparison
Secondary	Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)	comparison with SAQ score and with ischemia severity	baseline
Secondary	Ischemia severity (comparison with SAQ score and with ischemia severity)	comparison with SAQ score and with atherosclerosis severity	baseline
Secondary	Medical therapy used for angina (comparison with SAQ score and ischemia severity)	comparison with SAQ score and ischemia severity	one year
Secondary	Major adverse cardiac events	death, MI, stroke, cardiovascular hospitalizations/ER visits	one year