Recruiting

Coronary Microvascular Dysfunction

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05634031

Conditions

Angina

Non-obstructive Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET imaging

Coronary CT angiogram

Functional Angiography

Treadmill exercise stress study

Study Details

Brief summary:

Angina is a common clinical symptom of ischemic heart disease, affecting up to 11 million people in the United States alone, and 112 million people globally. Despite this, 4 in 10 patients undergoing elective coronary angiography for angina and ischemia do not have evidence of obstructive coronary artery disease (CAD). This condition of ischemia with no obstructive CAD (INOCA) is associated with high clinical and economic morbidity, as these patients have a higher rate of repeat procedures and hospitalizations, worse quality of life, future adverse cardiovascular events and frequent time missed from work.

The overall objective of this study is to develop and validate a non-invasive algorithm for diagnosis and management of patients with INOCA and suspected microvascular dysfunction centered around cardiac PET MPI. A secondary goal of the study is to assess for improvement in patient symptoms, function and quality of life from PET-guided management of CMD in patients with INOCA.

This study will take place at Mount Sinai Morningside in the PET and CTunit on the 3rd floor. The sub-study will occur at Mount Sinai Morningside Cath Lab on the 3rd floor. The study will enroll an estimated total of 70 subjects, 12 of which will also participate in the sub-study. The study is estimated to last 2 years.

Conditions

Angina

Non-obstructive Coronary Artery Disease

Study ID

NCT05634031

Start date

Apr 26, 2023

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Patients with symptoms of exertional angina and/or dyspnea (confirmed on Seattle Angina Questionnaire and Rose Dyspnea Questionnaire)
  • Evidence of non-obstructive CAD on CCTA or coronary angiography (no stenosis >50% and/or FFR if performed >0.80)

Exclusion criteria:

  • Patients with reduced LVEF (<50%) or diagnosis of cardiomyopathy
  • Patients with co-existent moderate or severe valve disease
  • Patients with eGFR <30 ml/min/m2
  • History of prior coronary revascularization
  • Non-coronary indication for CCTA or coronary angiogram determining eligibility
  • Contraindications to regadenoson (severe asthma/chronic obstructive pulmonary disease, brady-arrhythmias, or systolic blood pressure <90 mm Hg)
  • Inability to provide informed consent
  • Pregnancy

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Patients with INOCA

Patients to undergo coronary angiogram and/or coronary CT angiogram for suspected ischemic symptoms of angina and dyspnea but do not have obstructive epicardial coronary artery disease.

Interventions

PET imaging

PET imaging visit, which will take approximately 1-2 hours.

Coronary CT angiogram

A coronary CT angiogram if the participant has not had one recently.

Functional Angiography

A subset of patients with abnormal results on cardiac PET myocardial perfusion imaging study (estimated number of patients = 12) will be invited to participate in an invasive sub-study wherein they would undergo detailed invasive coronary physiology evaluation.

Functional Angiography (coronary reactivity test- CRT): is an angiography procedure done in the catheterization laboratory. It evaluates the coronary artery microcirculation and how the blood vessels respond to different medications.

Treadmill exercise stress study

A treadmill exercise stress study

Primary outcome measure

  • The Seattle Angina Questionnaire (SAQ) [ Time Frame: 3 months ]
  • Rose Dyspnea Scale (RDS) [ Time Frame: 3 months ]
  • Euro-QOL 5 Dimension Visual Analog Scale (EQ5D-VAS) [ Time Frame: 3 months ]
  • Number of ER admissions for chest pain per participant [ Time Frame: 3 months ]
  • Number of use of other invasive or non-invasive diagnostic procedures for CAD [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Nikhil K Sirga

(203) 455-6420NikhilKumar.Sirga@mountsinai.org

Lilia Soriano, BS

(929) 736-1828lilia.soriano@mountsinai.org

Locations

Mount Sinai Morningside

Recruiting

New York, New York, United States, 10025

Principal Investigator:

Krishna Patel, MBBS, MSc

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-07-16.