NCT05634031Recruiting
Imaging Coronary Microvascular Dysfunction (CMD) Study
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)
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 21 Nov 2022
- Start date
- 26 Apr 2023
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Coronary artery disease
- NCT number
- NCT05634031
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 26 Apr 2023 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior coronary revascularization
Other illness
- Patients with co-existent moderate or severe valve disease
- Contraindications to regadenoson (severe asthma/chronic obstructive pulmonary disease, brady-arrhythmias, or systolic blood pressure \<90 mm Hg)
Lab values
- Patients with reduced LVEF (\<50%) or diagnosis of cardiomyopathy
- Patients with eGFR \<30 ml/min/m2
Other
- Non-coronary indication for CCTA or coronary angiogram determining eligibility
- Inability to provide informed consent
- Pregnancy
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Morningside Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.