Vascular Endothelial Inflammation and Health Status In INOCA (VISION-INOCA)

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07586241
Status
Not Yet Recruiting

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Conditions

  • Ischemia and Non-obstructive Coronary Arteries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Invasive coronary angiography — PROCEDURE
    Participant will undergo invasive coronary angiography as clinically indicated (standard of care).
  • Coronary Artery Endothelial Cell Sampling — PROCEDURE
    Endothelial cells will be obtained from clinical coronary guidewires after retrieval from the guide catheter.
  • Fitbit — DEVICE
    Wearable activity monitoring device that measures physical activity based on the number of steps per day. The device also tracks sleep efficiency (exploratory) through a proprietary algorithm, and other health metrics. Daily step count and heart rate are recorded on the wearable device.
  • Invasive coronary function testing — DIAGNOSTIC_TEST
    Participants will undergo invasive coronary function testing as clinically indicated (standard of care).

Study Details

The purpose of this study is to evaluate coronary artery and peripheral vein vascular endothelial profiles in patients with ischemia with non-obstructive coronary arteries (INOCA) who undergo coronary function testing (CFT). The aims are: (1) Evaluate coronary artery endothelial profiles and associations with coronary microvascular dysfunction (CMD) in INOCA. (2) Assess brachial vein endothelial cell profiles in patients with INOCA and associations with CMD, and (3) Characterize relationships between endothelial signatures and anginal symptoms, functional status, and physical activity at baseline and 1-year follow-up.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Mar 1, 2031

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: Non-Obstructive CAD
    Participants with ischemia with non-obstructive coronary arteries (INOCA) and endothelial sampling will be fully eligible for long-term follow up. A Wearable activity monitoring device (Fitbit) will be provided post-procedure to these participants. Participants will be followed for a minimum of 1 year.
  • Arm: Obstructive CAD
    Participants with obstructive coronary artery disease (CAD) at the time of angiography may undergo endothelial sampling and blood collection but will not be provided a wearable activity monitoring device or undergo long-term follow up.

Primary Outcome Measure

Change in Seattle Angina Questionnaire (SAQ) score [ Time Frame: Baseline, 1 year follow up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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NYU Langone Health· New York, NY