Non-Obstructive Coronary AtherosclerosisPOINT-NOCADNCT05031520
PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease
An observational study of Non-Obstructive Coronary Atherosclerosis, run by NYU Langone Health at 1 site in United States.
Trial summary
Among patients with ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Myocardial infarction (MI) with non-obstructive coronary artery disease (MINOCA) accounts for 5-20% of patients with MI and preferentially affects women. Read more about this study
- Who is it for?
- Ages 18 to 125 years
- Conditions the study is for
- Non-Obstructive Coronary Atherosclerosis
- What is being tested?
- Coronary computed tomography angiography (CCTA), Isovue and Nitroglycerin
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 125 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults presenting to the NYU Langone Health Tisch/Kimmel Cardiac Catheterization Laboratory or the Bellevue Cardiac Catheterization laboratory will be screened and approached for consent if the patient's treating provider is amenable to their participation in the research study and if the patient is eligible for enrollment based on the eligibility criteria prior to clinically indicated cardiac catheterization.
Who may be able to join
- Adult age ≥18 years referred for clinically indicated coronary angiography
- Stable ischemic heart disease OR acute myocardial infarction as the indication for coronary angiography
Who cannot join
- Clinical Exclusion criteria:
- Estimated glomerular filtration rate < 45 mL/min
- History of allergic reaction to iodinated contrast media
- Pregnancy
- Angiographic / Post-Cath Exclusion criteria:
- Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
- Allergic reaction to iodinated contrast media
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Study of Perivascular Coronary Inflammation in Patients With Myocardial Ischemia or Infarction With Non-Obstructive Coronary Arteries
Among patients with ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Myocardial infarction (MI) with non-obstructive coronary artery disease (MINOCA) accounts for 5-20% of patients with MI and preferentially affects women. MINOCA pathogenesis is varied and may include atherosclerotic plaque rupture, plaque erosion with thrombosis, vasospasm, embolization, dissection or a combination of mechanisms. Other patients may have clinically unrecognized myocarditis, or takotsubo syndrome masquerading as MI. Among patients referred for coronary angiography for the evaluation of stable ischemic heart disease, non-obstructive CAD is present in up to ~30% of men and ~60% of women. Stable ischemia with non-obstructive coronary arteries (INOCA) may be due to coronary microvascular dysfunction in up to 40% of these patients. Our understanding of mechanisms of MINOCA and INOCA remain incomplete. Coronary inflammation has been hypothesized as a potential mechanism contributing to coronary spasm in MINOCA and microvascular disease in INOCA.
Read the detailed description
The PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease (POINT-NOCAD) study is a single-center diagnostic, observational study enrolling men and women with MINOCA or INOCA who are planned to undergo (or underwent) clinically indicated coronary angiography. The research plan is to evaluate coronary inflammation, as measured by the perivascular coronary fat attenuation index from non-invasive coronary computed tomography angiography (CCTA), in patients with MINOCA and INOCA.
- Conditions
- Non-Obstructive Coronary Atherosclerosis
- Being tested
- Coronary computed tomography angiography (CCTA), Isovue, Nitroglycerin, Metoprolol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary computed tomography angiography (CCTA)Procedure or surgery
Participants will undergo CCTA. CCTA performed in this study will be technically identical to CCTA that is commonly performed in clinical practice, for which safety profiles are well defined. Guidelines implemented by the National Institutes of Health Radiation Exposure Committee will be followed. Major risks of CCTA include exposure to ionizing radiation, the requirement for intravenous catheter placement and contrast media administration, and side effects of beta-blockers and nitrates that may be used for vasodilation and heart rate control to optimize CCTA image quality.
IsovueDrug
CCTA requires intravenous catheter placement and the administration of iodinated contrast media (Isovue).
NitroglycerinDrug
Medication to promote coronary vasodilation during the CCTA may be administered immediately prior to CCTA to optimize image quality
MetoprololDrug
Medication to promote heart rate reduction during the CCTA may be administered immediately prior to CCTA to optimize image quality
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Participants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA. Receives: Procedure: Coronary computed tomography angiography (CCTA); Drug: Isovue; Drug: Nitroglycerin; Drug: Metoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perivascular coronary fat attenuation will be significantly greater in MINOCA patients compared with INOCA patients
Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units [HU]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Measured: Visit 1, Day 0
Perivascular coronary fat attenuation will be greater in INOCA patients with versus without coronary microvascular disease
Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units [HU]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Measured: Visit 1, Day 0
Perivascular coronary fat attenuation in patients with MINOCA will be greatest in the culprit coronary vessels with evidence of acute plaque disruption.
Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units [HU]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Measured: Visit 1, Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start12 Jul 2021
- Primary completion1 Sep 2024
- Study completion31 Dec 2024
Why it stopped: Study was terminated due to funding expiration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Obstructive Coronary AtherosclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
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
- NCT05031520
- Sponsor's protocol ID
- 21-00764
- Acronym
- POINT-NOCAD
- Status last verified
- Apr 2025
- First submitted
- 24 Aug 2021
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Study of Perivascular Coronary Inflammation in Patients With Myocardial Ischemia or Infarction With Non-Obstructive Coronary Arteries
- ClinicalTrials.gov ID
- NCT05031520
- Acronym / sponsor ID
- POINT-NOCAD / 21-00764
- Conditions
- Non-Obstructive Coronary Atherosclerosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated due to funding expiration.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Sep 2021 (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.
Among patients with ischemic heart disease who are referred for coronary angiography, a substantial proportion have non-obstructive coronary artery disease (CAD). Myocardial infarction (MI) with non-obstructive coronary artery disease (MINOCA) accounts for 5-20% of patients with MI and preferentially affects women. MINOCA pathogenesis is varied and may include atherosclerotic plaque rupture, plaque erosion with thrombosis, vasospasm, embolization, dissection or a combination of mechanisms. Other patients may have clinically unrecognized myocarditis, or takotsubo syndrome masquerading as MI. Among patients referred for coronary angiography for the evaluation of stable ischemic heart disease, non-obstructive CAD is present in up to ~30% of men and ~60% of women. Stable ischemia with non-obstructive coronary arteries (INOCA) may be due to coronary microvascular dysfunction in up to 40% of these patients. Our understanding of mechanisms of MINOCA and INOCA remain incomplete. Coronary inflammation has been hypothesized as a potential mechanism contributing to coronary spasm in MINOCA and microvascular disease in INOCA.
Detailed description
The PericOronary INflammaTion in Non-Obstructive Coronary Artery Disease (POINT-NOCAD) study is a single-center diagnostic, observational study enrolling men and women with MINOCA or INOCA who are planned to undergo (or underwent) clinically indicated coronary angiography. The research plan is to evaluate coronary inflammation, as measured by the perivascular coronary fat attenuation index from non-invasive coronary computed tomography angiography (CCTA), in patients with MINOCA and INOCA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Procedure: Coronary computed tomography angiography (CCTA), Drug: Isovue, Drug: Nitroglycerin, Drug: MetoprololParticipants will be identified by review of the cardiac catheterization laboratory schedule each day by the principal investigator, a co-investigator, or a research coordinator. Participants with no obstructive CAD and completed microvascular testing will undergo a research CCTA. |
Who may qualify
- Ages
- 18 to 125 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting to the NYU Langone Health Tisch/Kimmel Cardiac Catheterization Laboratory or the Bellevue Cardiac Catheterization laboratory will be screened and approached for consent if the patient's treating provider is amenable to their participation in the research study and if the patient is eligible for enrollment based on the eligibility criteria prior to clinically indicated cardiac catheterization.
Key inclusion criteria (2 listed)
- Adult age ≥18 years referred for clinically indicated coronary angiography
- Stable ischemic heart disease OR acute myocardial infarction as the indication for coronary angiography
Key exclusion criteria (7 listed)
- Estimated glomerular filtration rate < 45 mL/min
- History of allergic reaction to iodinated contrast media
- Pregnancy
- Obstructive CAD (≥50% luminal obstruction in ≥1 major epicardial coronary arteries by invasive coronary angiography)
- Allergic reaction to iodinated contrast media
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 |
|---|---|---|
| Coronary computed tomography angiography (CCTA)Participants will undergo CCTA. CCTA performed in this study will be technically identical to CCTA that is commonly performed in clinical practice, for which safety profiles are well defined. Guidelines implemented by the National Institutes of Health Radiation Exposure Committee will be followed. Major risks of CCTA include exposure to ionizing radiation, the requirement for intravenous catheter placement and contrast media administration, and side effects of beta-blockers and nitrates that may be used for vasodilation and heart rate control to optimize CCTA image quality. | Procedure or surgery | Intervention group |
| IsovueCCTA requires intravenous catheter placement and the administration of iodinated contrast media (Isovue). | Drug | Intervention group |
| NitroglycerinMedication to promote coronary vasodilation during the CCTA may be administered immediately prior to CCTA to optimize image quality | Drug | Intervention group |
| MetoprololMedication to promote heart rate reduction during the CCTA may be administered immediately prior to CCTA to optimize image quality | Drug | Intervention group |
Primary outcome
Perivascular coronary fat attenuation will be significantly greater in MINOCA patients compared with INOCA patients
Time frame: Visit 1, Day 0
Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units [HU]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Perivascular coronary fat attenuation will be greater in INOCA patients with versus without coronary microvascular disease
Time frame: Visit 1, Day 0
Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units [HU]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Perivascular coronary fat attenuation in patients with MINOCA will be greatest in the culprit coronary vessels with evidence of acute plaque disruption.
Time frame: Visit 1, Day 0
Images obtained from the CCTA will be used to calculate perivascular FAI, measured around the proximal left anterior descending artery and in the right coronary artery, in the proximal 10 to 50 mm of the vessel. For each coronary vessel, will define the weighted mean attenuation of all adipose tissue-containing voxels (-190 to -30 Hounsfield units [HU]) located within a radial distance from the outer vessel wall equal to the diameter of the respective vessel.
Results and safety
The study was stopped early (reason given: Study was terminated due to funding expiration.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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. This study is not recruiting at the moment.
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 Non-Obstructive Coronary Atherosclerosis, 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Apr 2025. 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?
The study was stopped early (reason given: Study was terminated due to funding expiration.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perivascular coronary fat attenuation will be significantly greater in MINOCA patients compared with INOCA patients (time frame: Visit 1, Day 0). The study lists 3 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 29 Apr 2025.