Ischemia and Non-obstructive Coronary Arteries
Conditions
Keywords
INOCA
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.
Interventions
PROCEDUREInvasive coronary angiography
Participant will undergo invasive coronary angiography as clinically indicated (standard of care).
PROCEDURECoronary Artery Endothelial Cell Sampling
Endothelial cells will be obtained from clinical coronary guidewires after retrieval from the guide catheter.
DEVICEFitbit
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_TESTInvasive coronary function testing
Participants will undergo invasive coronary function testing as clinically indicated (standard of care).
Sponsors
NYU Langone Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Seattle Angina Questionnaire (SAQ) score | 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. |
| Change in Duke Activity Status Index (DASI) score | 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. |
Countries
United States
Contacts
CONTACTNathaniel Smilowitz, MD
CONTACTManuela Plazas Montana
PRINCIPAL_INVESTIGATORNathaniel Smilowitz, MD
NYU Langone Health
Outcome results
None listed