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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ischemia and Non-obstructive Coronary Arteries
• Intervention / Treatment: Procedure: Invasive coronary angiography; Procedure: Coronary Artery Endothelial Cell Sampling; Device: Fitbit; Diagnostic test: Invasive coronary function testing

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Nathaniel Smilowitz, MD; Phone Number: 212-263-5656; Email: nathaniel.smilowitz@nyulangone.org
• Study Contact Backup: Name: Manuela Plazas Montana; Phone Number: 917-921-6436; Email: inoca@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult men and women age ≥18 with suspected INOCA who are planned to undergo clinically indicated coronary function testing.

Description

Inclusion Criteria:

1. Adult age ≥18 years referred for clinically indicated coronary angiography
2. Chronic coronary disease or potentially ischemic symptoms as the indication for coronary angiography
3. Possible or suspected ischemia with non-obstructive epicardial coronary arteries (INOCA)

Exclusion Criteria:

Clinical (Pre-Cath) Exclusion criteria:

1. Anemia (hemoglobin <9 mg/dl)
2. Severe valvular heart disease
3. Acute myocardial infarction within 30 days
4. Severe valvular heart disease
5. New York Heart Association (NYHA) Functional Class III or IV heart failure
6. Hypertrophic obstructive cardiomyopathy or severe left ventricular hypertrophy
7. Pregnancy (because of potential exercise/activity limitations and symptom changes)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Invasive coronary angiography; Participant will undergo invasive coronary angiography as clinically indicated (standard of care).; Procedure: Coronary Artery Endothelial Cell Sampling; Endothelial cells will be obtained from clinical coronary guidewires after retrieval from the guide catheter.; Device: Fitbit; 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.; Diagnostic test: Invasive coronary function testing; Participants will undergo invasive coronary function testing as clinically indicated (standard of care).
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.	Procedure: Invasive coronary angiography; Participant will undergo invasive coronary angiography as clinically indicated (standard of care).; Procedure: Coronary Artery Endothelial Cell Sampling; Endothelial cells will be obtained from clinical coronary guidewires after retrieval from the guide catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Nathaniel Smilowitz, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: INOCA
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia
• Other Study ID Numbers: 25-01265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No