NCT05634031 Imaging Coronary Microvascular Dysfunction (CMD) Study
| NCT ID | NCT05634031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Angina |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-04-26 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-04-26 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Krishna Patel, MBBS, MSc
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05634031 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Angina. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05634031 currently recruiting?
Yes, NCT05634031 is actively recruiting participants. Contact the research team at NikhilKumar.Sirga@mountsinai.org for enrollment information.
Where is the NCT05634031 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05634031 clinical trial?
NCT05634031 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Krishna Patel, MBBS, MSc at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 60 participants.