Vascular Endothelial Inflammation and Health Status In INOCA (VISION-INOCA)
A Single Center Diagnostic Study of Endothelial Inflammation and Health Status in Patients With Ischemia and Nonobstructive Coronary Arteries (INOCA)
1 other identifier
observational
250
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2026
CompletedFirst Submitted
Initial submission to the registry
May 8, 2026
CompletedFirst Posted
Study publicly available on registry
May 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
May 14, 2026
May 1, 2026
4.7 years
May 8, 2026
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Seattle Angina Questionnaire (SAQ) score
The Seattle Angina Questionnaire (SAQ) scores range from 0 to 100 for all five domains (Physical Limitations, Angina Stability, Angina Frequency, Treatment Satisfaction, and Quality of Life), with higher scores indicating better health status, fewer limitations, and less frequent angina. A 10-point change in score is typically considered clinically significant.
Baseline, 1 year follow up
Change in Duke Activity Status Index (DASI) score
The DASI is a 12-item self-report questionnaire used to assess a patient's functional capacity. Scores range from 0 to 58.2, with higher scores indicating better functional capacity.
Baseline, 1 year follow up
Study Arms (2)
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.
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.
Interventions
Participant will undergo invasive coronary angiography as clinically indicated (standard of care).
Endothelial cells will be obtained from clinical coronary guidewires after retrieval from the guide catheter.
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.
Participants will undergo invasive coronary function testing as clinically indicated (standard of care).
Eligibility Criteria
Adult men and women age ≥18 with suspected INOCA who are planned to undergo clinically indicated coronary function testing.
You may qualify if:
- Adult age ≥18 years referred for clinically indicated coronary angiography
- Chronic coronary disease or potentially ischemic symptoms as the indication for coronary angiography
- Possible or suspected ischemia with non-obstructive epicardial coronary arteries (INOCA)
You may not qualify if:
- Anemia (hemoglobin \<9 mg/dl)
- Severe valvular heart disease
- Acute myocardial infarction within 30 days
- Severe valvular heart disease
- New York Heart Association (NYHA) Functional Class III or IV heart failure
- Hypertrophic obstructive cardiomyopathy or severe left ventricular hypertrophy
- Pregnancy (because of potential exercise/activity limitations and symptom changes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
Biospecimen
Biospecimens will be labeled with a unique study code and stored for future use; no other identifying information will be stored in the laboratory database.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathaniel Smilowitz, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2026
First Posted
May 14, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
December 31, 2030
Study Completion (Estimated)
March 1, 2031
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to nathaniel.smilowitz@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB. Study data will also be submitted to publicly available databases. NHLBI BioData Catalyst (BDC) will provide long-term access to de-identified dataset(s). RNA sequencing data will be deposited into the NCBI Gene Expression Omnibus (GEO) database, a public functional genomics data repository. Data will be made available at the time of associated publication, as per NIH policy.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to nathaniel.smilowitz@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.