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

Not Applicable

Not yet recruiting

• Conditions: Ischemic Heart Disease (IHD); Cardiac Magnetic Resonance Imaging; Myocardial Blood Flow
• Interventions: Diagnostic Test: Qualitative Myocardial Blood Flow Evaluation; Diagnostic Test: Quantitative Myocardial Blood Flow Evaluation; Drug: Gadavist; Drug: Vasodilator; Diagnostic Test: Blood draw for the laboratory assessment

• Registration Number: NCT06854458
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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.

Detailed Description

In this proposal of the Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States (SPINS2) study, the investigators seek to assess the prognostic utility of myocardial blood flow and flow reserve by quantitative stress cardiac magnetic resonance imaging compared to patients with normal quantitative perfusion indices. The investigators hypothesize that patients with abnormal myocardial blood flow and flow reserve will have higher adverse cardiac events, incremental to demographic risks and qualitative perfusion, and they should be considered for invasive workup or early institution of goal-directed medical therapies. In addition, the investigators hypothesize that quantitative perfusion by cardiac magnetic resonance imaging will characterize the myocardial extent and severity of multivessel disease and the participants' risk of adverse cardiac outcomes.

Patients with chest pain syndromes and suspected ischemic heart disease who meet both inclusion and exclusion criteria will be prospectively recruited among 20 sites across the United States over the course of 1.5 years. Participants will receive standardized quantitative stress cardiac magnetic resonance imaging protocol with Gadavist (Bayer, Germany) 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg) as per Food and Drug Administration (FDA)-approved indication. All participants will receive vasodilator stress with regadenoson or adenosine depending on local site practice. A single (7-10 ml tube) whole blood sample will be collected from each patient for processing of blood biomarkers.

All participants will have demographics and imaging characteristics recorded at baseline visits. Follow-up will occur via email or telephone at 3 months, 12 months, and 24 months from baseline. At each follow-up visit, medications, treatment, and adverse events will be recorded. In addition, all available electronic patient records will be reviewed in detail to capture all follow-up data which will be entered into an outline database using clearly defined data definitions. Participants will be followed for a total of 2 years from baseline cardiac magnetic resonance imaging study.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-24
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study Start: 2025-03
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2029-01
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. male or female at age 35-85 years,

2. presence of either of the following sign/symptom that led to a referral to stress cardiac magnetic resonance imaging:

   1. chest pain or anginal equivalent, or
   2. abnormal electrocardiogram with a suspicion of coronary artery disease

3. Intermediate or high risk of significant coronary disease based on at least 1 of the following conditions:

   a) patient age > 45 for male, 50 for female b) Diabetes, hypertension, or hypercholesterolemia: by either history or medical treatment c) family history of premature coronary disease: first degree relative at age <= 55 male and <=65 female d) history of smoking of > 10 packed-years e) post-menopausal state >5 years f) any chronic inflammatory conditions d) Body mass index > 30 e) Any medical documentation of coronary or peripheral artery disease

Exclusion Criteria

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

2. Confirmed diagnosis of any significant non-coronary cardiac conditions below:

   1. any severe-grade valvular heart disease,
   2. left ventricular ejection fraction <40% from any known non-coronary causes,
   3. infiltrative cardiomyopathy,
   4. hypertrophic cardiomyopathy,
   5. pericardial disease with significant constriction, or

3. active pregnancy,

4. any competing conditions leading to an expected survival of < 2 years

5. contraindication to vasodilator (regadenoson or adenosine)

6. metallic device or object that poses an magnetic resonance imaging safety hazard

7. metallic device with a high likelihood of non-diagnostic cardiac magnetic resonance images

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Myocardial Blood Flow Evaluation	Qualitative Myocardial Blood Flow Evaluation	Qualitative stress cardiac magnetic resonance imaging only.
Standard Myocardial Blood Flow Evaluation	Gadavist	Qualitative stress cardiac magnetic resonance imaging only.
Standard Myocardial Blood Flow Evaluation	Vasodilator	Qualitative stress cardiac magnetic resonance imaging only.
Standard Myocardial Blood Flow Evaluation	Blood draw for the laboratory assessment	Qualitative stress cardiac magnetic resonance imaging only.
New Myocardial Blood Flow Evaluation	Quantitative Myocardial Blood Flow Evaluation	Quantitative + Qualitative stress cardiac magnetic resonance imaging.
New Myocardial Blood Flow Evaluation	Gadavist	Quantitative + Qualitative stress cardiac magnetic resonance imaging.
New Myocardial Blood Flow Evaluation	Vasodilator	Quantitative + Qualitative stress cardiac magnetic resonance imaging.
New Myocardial Blood Flow Evaluation	Blood draw for the laboratory assessment	Quantitative + Qualitative stress cardiac magnetic resonance imaging.

Primary Outcome Measures

Name	Time	Method
Primary composite outcome of major cardiovascular adverse events (MACE)	From cardiac magnetic resonance imaging to the end of follow-up in 24 months	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.

Secondary Outcome Measures

Name	Time	Method
Procedure-related complications	From cardiac magnetic resonance imaging to the end of follow-up in 24 months	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).
Cost outcomes for Comparative Cost-effectiveness	From cardiac magnetic resonance imaging to the end of follow-up in 24 months	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States