Cardiovascular Interventions for Coronary Microvascular Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the link between coronary microvascular dysfunction (a heart issue affecting small blood vessels) and heart failure with preserved ejection fraction (HFpEF), where the heart pumps normally but is stiff when relaxed. Researchers are studying how factors like high blood pressure, high cholesterol, and diabetes might make small blood vessels in the heart more prone to problems that could lead to heart failure. The trial includes tests such as heart scans and stress tests to better understand these conditions. Women with chest pain but no major artery blockages, as well as both women and men with signs of heart failure but normal pumping function, might be suitable for the trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to better understanding and treatment of heart conditions.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments under study for coronary microvascular disease (CMD) are generally safe and well-tolerated. Tests that relax the aorta have been found to be as safe as routine coronary angiography, a common heart procedure with a known safety record.
Cardiac Magnetic Resonance Imaging (CMR) is another method used to assess CMD. CMR does not use radiation and is considered safe, though it can be expensive.
Computed Coronary Tomographic Angiography (CCTA) examines heart arteries. Research indicates it is very safe and involves low radiation exposure.
Coronary Angiography, which examines the heart's blood vessels, carries minimal risk when safety guidelines are followed.
Coronary Reactivity Testing assesses how heart blood vessels respond to stress and is generally safe, with some studies noting minor risks.
Rest-Stress Millar Testing, used to measure heart stress, is also considered safe according to research.
Overall, these treatments have been studied and are considered safe, making them suitable for further exploration in clinical trials.12345Why are researchers excited about this trial?
Researchers are excited about the WISE CVD trial because it is exploring advanced diagnostic techniques for heart conditions that are not fully understood, particularly in women. Unlike traditional methods which often rely on detecting obstructive coronary artery disease, this trial uses sophisticated imaging and testing methods like Cardiac Magnetic Resonance Imaging and Coronary Reactivity Testing to assess heart function and blood flow in patients with signs of ischemia and heart failure with preserved ejection fraction (HFpEF). These methods aim to offer a more comprehensive view of coronary function and could lead to better-targeted treatments for patients who don’t fit the typical profile of heart disease, potentially filling a significant gap in current diagnostic practices.
What evidence suggests that this trial's treatments could be effective for Coronary Microvascular Disease?
Research has shown that coronary microvascular dysfunction (CMD), a condition affecting the small blood vessels in the heart, links to serious heart problems. Studies indicate that CMD can nearly quadruple the risk of death and increase the chance of major heart events fivefold. This trial evaluates techniques like cardiac MRI and CCTA for their effectiveness in diagnosing CMD and predicting heart health risks. Coronary reactivity testing, another method under study, also helps identify CMD and prevent misdiagnosis. These methods provide a clearer understanding of CMD, aiding in better treatment and management of the condition.56789
Who Is on the Research Team?
C. Noel Bairey Merz, MD, FACC
Principal Investigator
Cedars-Sinai Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Evaluation
Baseline evaluation including noninvasive high resolution, comprehensive CMRI imaging, invasive angiography, coronary reactivity testing, and rest-stress Millar pressure-volume measurement
Treatment/Intervention
Participants undergo CMRI, MR Coronary Angiography, and noninvasive computed coronary tomographic angiography to understand links between CMD, diastolic function, and HFpEF
Follow-up
Participants are monitored for safety and effectiveness after treatment, with long-term follow-up for up to 30 years to assess persistent chest pain symptoms and quality of life outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Aortic vasorelaxation tests
- Cardiac Magnetic Resonance Angiography
- Cardiac Magnetic Resonance Imaging
- Computed Coronary Tomographic Angiography
- Coronary Angiography
- Coronary Reactivity Testing
- Rest-Stress Millar Testing
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Women and men hospitalized for signs and symptoms of ischemia and evidence of Heart Failure with preserved ejection fraction (HFpEF) who have not undergone a clinically-ordered coronary angiography
Women undergoing clinically-ordered coronary angiography for signs and symptoms of ischemia who have no obstructive coronary artery disease (CAD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor
Citations
Prognostic impact of coronary microvascular dysfunction ...
This study indicates that the AMR is significantly related to poor prognosis among patients with ACS and CKD.
Coronary microvascular dysfunction and cardiovascular ...
More than 50% of the coronary microvascular perfusion in the infarcted area of STEMI patients decreased[48], and platelet aggregation resulted in microembolism ...
A Systematic Review and Meta‐Analysis of Aggregate Data
CMD is associated with a nearly 4-fold increase in mortality and a 5-fold increase in major adverse cardiac events.
Impact of invasive aortic pulse pressure on coronary ...
Aortic stiffness is associated with coronary microvascular dysfunction in patients with non-obstructive coronary artery disease. Intern Med ...
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frontiersin.org
frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1111721/fullCoronary microvascular dysfunction: A review of recent ...
This review explores the diagnosis and pathogenic role of CMD across a range of cardiovascular diseases, its prognostic significance, and the current ...
Coronary Microvascular Disease in Contemporary Clinical ...
This review describes the clinical implications of CMD and relevant invasive methods for CMD assessment in the cardiac catheterization laboratory.
Coronary microvascular disease: current concepts of ...
Coronary microvascular disease (CMD) is present in 30% of patients with angina and is associated with increased morbidity and mortality.
Invasive evaluation of coronary microvascular dysfunction
This review summarizes the most widespread approaches for the invasive evaluation of CMD, with a focus on patients with ischemia and non-obstructive CAD.
Multicenter Prospective Assessment of Coronary ...
In a prospective assessment of invasive testing for CMD/VSA, we observed varied procedural and technical approaches. Testing was rapid, and a ...
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