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The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study

ConditionsIschemic Heart Disease (IHD)Cardiac Magnetic Resonance ImagingMyocardial Blood Flow
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-85
SponsorBrigham and Women's Hospital

About this trial

This research aims to investigate whether symptoms of chest pain or shortness of breath among the study population are arising due to a heart problem, particularly any reduction of blood flow to the heart muscle from blockages in the coronary blood vessels or inflammation of the heart using cardiac magnetic resonance imaging that measures the amount of blood flow during a stress state meant to simulate vigorous exercise. At present, doctors use standard magnetic resonance imaging pictures of blood flow patterns to treat heart disease. The investigators want to study if detailed blood flow measurements, in addition to the standard blood flow pattern, could diagnose heart disease more accurately and allow more doctors to understand the severity of heart disease. Early research has demonstrated that detailed blood flow measurements may be more accurate in diagnosing heart disease in some patients, but doctors need more information to know how to use these measurements.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

male or female at age 35-85 years,

chest pain or anginal equivalent, or

abnormal electrocardiogram with a suspicion of coronary artery disease

Disqualifiers

Acute myocardial infarction within the past 30 days prior to cardiac magnetic resonance imaging

any severe-grade valvular heart disease,

left ventricular ejection fraction <40% from any known non-coronary causes,

infiltrative cardiomyopathy,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Quantitative Myocardial Blood Flow Evaluation

    Diagnostic test

    The perfusion sequence will produce on-the-fly additional quantitative perfusion maps with segmental myocardial blood flow values.

  • Qualitative Myocardial Blood Flow Evaluation

    Diagnostic test

    The perfusion sequence will not produce additional quantitative perfusion maps.

  • Gadavist

    Drug

    Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).

  • Vasodilator

    Drug

    All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).

  • Blood draw for the laboratory assessment

    Diagnostic test

    A single (7-10 ml tube) whole blood sample will be collected from each patient for processing of blood biomarkers.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Standard Myocardial Blood Flow EvaluationActive comparator 4 interventions
Group B: New Myocardial Blood Flow EvaluationExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Primary composite outcome of major cardiovascular adverse events (MACE)

Composite MACE includes cardiovascular death, non-fatal acute myocardial infarction, stroke, resuscitated cardiac arrest, unnecessary invasive coronary angiography, and any cardiac hospitalization. Unnecessary invasive coronary angiography is defined as any invasive coronary angiography performed within 6 months after study enrollment, which reviews no obstructive coronary disease and no revascularization performed.

Time frame
From cardiac magnetic resonance imaging to the end of follow-up in 24 months

Secondary outcomes

1

Procedure-related complications

Serious complications from a coronary procedure (e.g., procedure-related myocardial infarction, stroke/Transient Ischemic Attack, major periprocedural bleeding, 50% reduction of estimated glomerular filtration rate (eGFR), or anaphylactic reaction).

Time frame
From cardiac magnetic resonance imaging to the end of follow-up in 24 months
2

Cost outcomes for Comparative Cost-effectiveness

Costs of performing coronary artery disease-related tests or procedures during the follow-up period, namely invasive coronary angiography; coronary revascularization procedure or surgery; any noninvasive stress imaging, stress electrocardiogram, or coronary computed tomography angiography imaging. Costs of performing these tests or procedures will be determined by national averaged Medicare cost of reimbursement adjusted across the years for rate of inflation.

Time frame
From cardiac magnetic resonance imaging to the end of follow-up in 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov
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