Vascular Endothelial Inflammation and Health Status In INOCA (VISION-INOCA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Invasive coronary angiography, Coronary Artery Endothelial Cell Sampling, Fitbit, Invasive coronary function testing.
- Who it may be relevant to
- Registry conditions: Ischemia and Non-obstructive Coronary Arteries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single Center Diagnostic Study of Endothelial Inflammation and Health Status in Patients With Ischemia and Nonobstructive Coronary Arteries (INOCA)
Overview
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.
Interventions
- 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).
Primary outcome measures
- Change in Seattle Angina Questionnaire (SAQ) score [Time frame: Baseline, 1 year follow up]
- Change in Duke Activity Status Index (DASI) score [Time frame: Baseline, 1 year follow up]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07586241 · 25-01265