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NCT Number: NCT07586241

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

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Key information

Conditions

Ischemia and Non-obstructive Coronary Arteries Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

Clinical (Pre-Cath) Exclusion criteria:

  • 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)

Treatment and study plan

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).

Primary outcomes

  1. Change in Seattle Angina Questionnaire (SAQ) score

    Time frame: Baseline, 1 year follow up

    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.

  2. Change in Duke Activity Status Index (DASI) score

    Time frame: Baseline, 1 year follow up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Manuela Plazas Montana

CONTACT

[email protected]

917-921-6436

Nathaniel Smilowitz, MD

CONTACT

[email protected]

212-263-5656

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Single Center Diagnostic Study of Endothelial Inflammation and Health Status in Patients With Ischemia and Nonobstructive Coronary Arteries (INOCA)

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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