Clinical trial NCT02347215: Changes in Ischemia and Angina Over 1 Year Among ISCHEMIA Trial Screen Failures With no Obstructive CAD on Coronary CT Angiography
Official title: Changes in Ischemia and Angina Over One Year Among ISCHEMIA Trial Screen Failures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microvascular Angina
Angina Pectoris
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
name: Massachusetts General Hospital
First posted: 2015-01-27
Enrollment: 212
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Seattle Angina Questionnaire (SAQ) score
timeFrame: baseline-one year comparison
Secondary outcomes:
measure: Ischemia severity
timeFrame: baseline-one year comparison
measure: Coronary atherosclerosis severity (comparison with SAQ score and with ischemia severity)
timeFrame: baseline
measure: Ischemia severity (comparison with SAQ score and with ischemia severity)
timeFrame: baseline
measure: Medical therapy used for angina (comparison with SAQ score and ischemia severity)
timeFrame: one year
measure: Major adverse cardiac events
timeFrame: one year
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Medical Center and Bellevue Hospital Center
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Judith Hochman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reynolds HR, Picard MH, Spertus JA, Peteiro J, Lopez Sendon JL, Senior R, El-Hajjar MC, Celutkiene J, Shapiro MD, Pellikka PA, Kunichoff DF, Anthopolos R, Alfakih K, Abdul-Nour K, Khouri M, Bershtein L, De Belder M, Poh KK, Beltrame JF, Min JK, Fleg JL, Li Y, Maron DJ, Hochman JS. Natural History of Patients With Ischemia and No Obstructive Coronary Artery Disease: The CIAO-ISCHEMIA Study. Circulation. 2021 Sep 28;144(13):1008-1023. doi: 10.1161/CIRCULATIONAHA.120.046791. Epub 2021 Jun 1.