Determining the Cause of Coronary Vasomotor Disorders in Patients With Ischemia and No Obstructive Coronary Artery Disease

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Suspected ischemic heart disease and is referred to undergo clinically indicated invasive coronary angiography

• No obstructive coronary artery disease (CAD) as defined by operator visual assessment with (1) angiographically normal coronary arteries OR (2) non-obstructive CAD with angiographic stenosis \< 50%, or greater than or equal to 50 but \< 70% with FFR greater than or equal to 0.81 or RFR greater than or equal to 0.90

• Willing to comply with specified follow-up evaluations. The participant or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Locations
United States
California
UCLA Health
RECRUITING
Los Angeles
Stanford Hospital
RECRUITING
Stanford
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Georgia
Northeast Georgia Medical Center
RECRUITING
Gainesville
New York
New York Presbyterian-Brooklyn Methodist Hospital
RECRUITING
Brooklyn
Columbia University Irving Medical Center
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
Ohio
The Christ Hospital
RECRUITING
Cincinnati
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Cody Pietras
cody.pietras@yale.edu
203) 737-5012
Backup
Samit Shah, MD, PhD
samit.shah@yale.edu
203-785-4129
Time Frame
Start Date: 2022-09-14
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 500
Authors
Sponsors
Leads: Yale University
Collaborators: Abbott

This content was sourced from clinicaltrials.gov