Imaging Techniques for Angina
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment Coronary CT angiogram, Functional Angiography, PET imaging, Positron Emission Tomography, PET scan, PET imaging, Treadmill exercise stress study for angina?
Research shows that imaging techniques like PET and CT scans are effective in diagnosing coronary artery disease (CAD) by providing detailed pictures of the heart's blood flow and structure. These methods help doctors make better decisions about managing CAD, which can lead to improved patient outcomes.12345
Is imaging for angina safe for humans?
Imaging techniques like SPECT and CT angiography have been studied for safety, showing that adverse events are generally mild and rare. For example, in one study, no serious events like heart attacks or severe complications were reported, suggesting these imaging methods are generally safe for humans.678910
How does this treatment for angina differ from other treatments?
This treatment for angina uses advanced imaging techniques like echocardiography, cardiac magnetic resonance, and computed tomography to diagnose and manage the condition. These imaging methods are non-invasive and provide detailed information about the heart's structure and function, which can help in making more accurate treatment decisions compared to traditional methods.1112131415
Research Team
Krishna Patel, MBBS, MSc
Principal Investigator
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
This trial is for patients with symptoms of exertional angina or shortness of breath, who have non-obstructive coronary artery disease confirmed by tests. It's not for those with severe kidney issues, certain heart conditions, pregnant women, or people unable to consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo Rb-82 rest-stress myocardial perfusion imaging PET with flow quantitation and an exercise treadmill test
Treatment
Participants receive PET-guided management recommendations for CMD, including medication adjustments
Follow-up
Participants are monitored for safety and effectiveness after treatment, including collection of patient symptoms and health status
Treatment Details
Interventions
- Coronary CT angiogram
- Functional Angiography
- PET imaging
- Treadmill exercise stress study
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor