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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive coronary angiography | Procedure | Participant will undergo invasive coronary angiography as clinically indicated (standard of care). |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Clinical (Pre-Cath) Exclusion criteria:
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Adult men and women age ≥18 with suspected INOCA who are planned to undergo clinically indicated coronary function testing.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathaniel Smilowitz, MD | Contact | 212-263-5656 | nathaniel.smilowitz@nyulangone.org | |
| Manuela Plazas Montana | Contact | 917-921-6436 | inoca@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Nathaniel Smilowitz, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| Coronary Artery Endothelial Cell Sampling | Procedure | Endothelial cells will be obtained from clinical coronary guidewires after retrieval from the guide catheter. |
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| 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. |
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| Invasive coronary function testing | Diagnostic Test | Participants will undergo invasive coronary function testing as clinically indicated (standard of care). |
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