Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05634031

Development and Validation of a Non-invasive Algorithm for Diagnosis of Microvascular Angina Among Patients With Ischemia and Non-obstructive Coronary Artery Disease (IMAGING-CMD Study)

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-04-16

70

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Angina, a common symptom of ischemic heart disease, affects millions worldwide, including up to 11 million people in the United States. Many patients undergoing tests for angina do not show blockage in their coronary arteries, a condition known as ischemia with no obstructive coronary artery disease (INOCA). This condition leads to more repeat procedures, hospital visits, worse quality of life, and increased future heart problems. The study aims to develop and confirm a non-invasive method to diagnose and manage microvascular angina in INOCA patients using cardiac PET myocardial perfusion imaging (MPI). Participants will undergo several tests including Rb-82 rest-stress PET with blood flow measurement, exercise treadmill testing if able, and possibly coronary CT angiography if not recently done. A smaller group with abnormal PET results will have an invasive angiography procedure to validate the PET findings. The study provides recommendations for treating microvascular dysfunction based on PET results, including medications like aspirin, statins, ACE-inhibitors, beta-blockers, calcium channel blockers, and ranolazine. Patient symptoms and healthcare usage will be tracked over three months. Throughout the study, patient risk factors, symptoms, medications, and health status will be recorded. Questionnaires assessing angina symptoms, breathlessness, and quality of life will be completed at three months. Researchers will also monitor emergency room visits for chest pain and use of other diagnostic procedures. Invasive physiology data and treatment recommendations will be shared with treating doctors after three months. The overall study duration is estimated to be two years, with about 70 participants enrolled.

CONDITIONS

Brief Title

Imaging Coronary Microvascular Dysfunction (CMD) Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with symptoms of exertional angina and/or dyspnea confirmed by Seattle Angina Questionnaire and Rose Dyspnea Questionnaire
  • Evidence of non-obstructive coronary artery disease on coronary CT angiography or coronary angiography (no stenosis >50% and/or FFR >0.80 if performed)
Not Eligible

You will not qualify if you...

  • Reduced left ventricular ejection fraction below 50% or diagnosis of cardiomyopathy
  • Moderate or severe valve disease
  • Estimated glomerular filtration rate less than 30 ml/min/m2
  • History of prior coronary revascularization
  • Non-coronary reasons for coronary CT angiography or angiogram to determine eligibility
  • Contraindications to regadenoson including severe asthma, chronic obstructive pulmonary disease, brady-arrhythmias, or low systolic blood pressure below 90 mm Hg
  • Inability to provide informed consent
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 months

Participants undergo PET imaging with rest-stress myocardial perfusion and treadmill exercise stress testing. Those without recent coronary CT angiography will have a coronary CT angiogram. A subset with abnormal PET results may undergo invasive functional angiography for detailed coronary physiology evaluation.

1 to 3 visits depending on imaging and invasive procedures

Long-term Monitoring

Duration - 3 months

Participants’ symptoms, health status, and resource use such as ER admissions and additional diagnostic procedures are monitored after diagnostic evaluations.

1 follow-up visit at 3 months

Trial Site Locations

Total: 1 location

1

Mount Sinai Morningside

New York, New York, United States, 10025

Actively Recruiting

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Research Team

L

Lilia Soriano, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Frequently Asked Questions

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