Imaging Coronary Microvascular Dysfunction (CMD) Study

This study is for people experiencing chest pain (angina) or shortness of breath (dyspnea) who have non-obstructive coronary artery disease (CAD), meaning their heart arteries are not significantly blocked. Researchers are using imaging tests like PET scans and CT angiograms, along with a treadmill exercise test, to better understand and diagnose coronary microvascular dysfunction (CMD). A small group of participants with abnormal PET scan results will also have an invasive procedure called functional angiography. The study aims to see if these methods improve symptoms and quality of life, measured at 3 months. You can join if you are 18 or older and meet specific symptom and heart health criteria, but not if you have reduced heart pumping ability or certain other conditions.

Study design
This is an interventional study planning to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo a PET imaging visit, possibly a coronary CT angiogram, and a treadmill exercise stress test. A subset of participants might also have a functional angiography procedure.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms and quality of life will be measured at 3 months after joining the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05634031

Imaging Coronary Microvascular Dysfunction (CMD) Study

Recruiting
NAAges 18+InterventionalDiagnostic
Icahn School of Medicine at Mount Sinai
~60 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:PET imagingCoronary CT angiogramFunctional AngiographyTreadmill exercise stress study

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The Seattle Angina Questionnaire (SAQ)
Measured over 3 months
+4 more outcomes measured
Angina
Non-obstructive Coronary Artery Disease
1 sites across 1 states
New York1
  • Krishna Patel, MBBS, MSc · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

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Eligibility criteria

Inclusion

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

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
  • The Seattle Angina Questionnaire (SAQ)3 months

    The Seattle Angina Questionnaire (SAQ) is a 7-item self-administered questionnaire with a 4-week recall period measuring health status in patients with CAD across 3 domains: physical limitation (PL), angina frequency (AF), and quality of life (QoL). Full scale from 0-100, with higher score indicating better health outcome.

  • Rose Dyspnea Scale (RDS)3 months

    Rose Dyspnea Scale (RDS) is a 4-item questionnaire with a 1-month recall period that assesses patients' level of dyspnea with common activities. Full scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea. Higher score indicates poorer health outcomes.

  • Euro-QOL 5 Dimension Visual Analog Scale (EQ5D-VAS)3 months

    Euro-QOL 5 Dimension Visual Analog Scale (EQ5D-VAS) The EQ-5D gives a measure of health-related quality of life. The visual analogue score is a measure of overall self-rated health status with full scale from 0-100. Higher scores indicate better health outcomes.

  • Number of ER admissions for chest pain per participant3 months

    The number of ER admissions for chest pain per participant.

  • Number of use of other invasive or non-invasive diagnostic procedures for CAD3 months

    The number of use of other invasive or non-invasive diagnostic procedures for CAD