Ischemia and Non-obstructive Coronary ArteriesNCT07586241
Vascular Endothelial Inflammation and Health Status In INOCA (VISION-INOCA)
An observational study of Ischemia and Non-obstructive Coronary Arteries, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia and Non-obstructive Coronary Arteries
- What is being tested?
- Invasive coronary angiography, Coronary Artery Endothelial Cell Sampling and Fitbit
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- May 2026to 1 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult men and women age ≥18 with suspected INOCA who are planned to undergo clinically indicated coronary function testing.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- Invasive coronary angiography, Coronary Artery Endothelial Cell Sampling, Fitbit, Invasive coronary function testing
- Keywords
- INOCA
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive coronary angiographyProcedure or surgery
Participant will undergo invasive coronary angiography as clinically indicated (standard of care).
Coronary Artery Endothelial Cell SamplingProcedure or surgery
Endothelial cells will be obtained from clinical coronary guidewires after retrieval from the guide catheter.
FitbitDevice
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 testingDiagnostic test
Participants will undergo invasive coronary function testing as clinically indicated (standard of care).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Invasive coronary angiography; Procedure: Coronary Artery Endothelial Cell Sampling; Device: Fitbit; Diagnostic Test: Invasive coronary function testing | |
| 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. Receives: Procedure: Invasive coronary angiography; Procedure: Coronary Artery Endothelial Cell Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study startMay 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia and Non-obstructive Coronary ArteriesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathaniel Smilowitz, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586241
- Sponsor's protocol ID
- 25-01265
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Diagnostic Study of Endothelial Inflammation and Health Status in Patients With Ischemia and Nonobstructive Coronary Arteries (INOCA)
- ClinicalTrials.gov ID
- NCT07586241
- Acronym / sponsor ID
- 25-01265
- Keywords
- INOCA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Obstructive CAD | – | Procedure: Invasive coronary angiography, Procedure: Coronary Artery Endothelial Cell Sampling, Device: Fitbit, Diagnostic Test: Invasive coronary function testingParticipants 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. |
| Obstructive CAD | – | Procedure: Invasive coronary angiography, Procedure: Coronary Artery Endothelial Cell SamplingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult men and women age ≥18 with suspected INOCA who are planned to undergo clinically indicated coronary function testing.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive coronary angiographyParticipant will undergo invasive coronary angiography as clinically indicated (standard of care). | Procedure or surgery | Non-Obstructive CAD, Obstructive CAD |
| Coronary Artery Endothelial Cell SamplingEndothelial cells will be obtained from clinical coronary guidewires after retrieval from the guide catheter. | Procedure or surgery | Non-Obstructive CAD, Obstructive CAD |
| FitbitWearable 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. | Device | Non-Obstructive CAD |
| Invasive coronary function testingParticipants will undergo invasive coronary function testing as clinically indicated (standard of care). | Diagnostic test | Non-Obstructive CAD |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathaniel Smilowitz, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemia and Non-obstructive Coronary Arteries, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathaniel Smilowitz, MD (212-263-5656, nathaniel.smilowitz@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Seattle Angina Questionnaire (SAQ) score (time frame: Baseline, 1 year follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.