Imaging for coronary microvascular dysfunction in patients with angina
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)
This study is testing a new way to use heart imaging to help people with chest pain and non-blocked arteries feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05634031 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and validate a non-invasive algorithm for diagnosing and managing patients with ischemia and non-obstructive coronary artery disease (INOCA) using cardiac PET imaging. Patients will undergo a series of tests including myocardial perfusion imaging with Rb-82, coronary CT angiography, and functional angiography if necessary. The study will also assess the impact of PET-guided management on patient symptoms, function, and quality of life. Data on patient risk factors and health status will be collected to support the study's objectives.
Who should consider this trial
Good fit: Ideal candidates include patients experiencing exertional angina or dyspnea with evidence of non-obstructive coronary artery disease.
Not a fit: Patients with reduced left ventricular ejection fraction, significant valve disease, or those who have undergone prior coronary revascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of patients suffering from angina due to microvascular dysfunction, enhancing their quality of life.
How similar studies have performed: While the approach of using PET imaging for CMD is gaining traction, this specific study's methodology is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Mount Sinai Morningside — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Krishna Patel, MBBS, MSc — Icahn School of Medicine at Mount Sinai
- Study coordinator: Lilia Soriano, BS
- Email: lilia.soriano@mountsinai.org
- Phone: (929) 736-1828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.