The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study
SPINS2
1 other identifier
interventional
1,000
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 3, 2025
CompletedStudy Start
First participant enrolled
June 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
May 5, 2026
February 1, 2026
3.5 years
February 24, 2025
May 4, 2026
Conditions
Keywords
Outcome Measures
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.
From cardiac magnetic resonance imaging to the end of follow-up in 24 months
Secondary Outcomes (2)
Procedure-related complications
From cardiac magnetic resonance imaging to the end of follow-up in 24 months
Cost outcomes for Comparative Cost-effectiveness
From cardiac magnetic resonance imaging to the end of follow-up in 24 months
Study Arms (2)
Standard Myocardial Blood Flow Evaluation
ACTIVE COMPARATORQualitative stress cardiac magnetic resonance imaging only.
New Myocardial Blood Flow Evaluation
EXPERIMENTALQuantitative + Qualitative stress cardiac magnetic resonance imaging.
Interventions
Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
The perfusion sequence will produce on-the-fly additional quantitative perfusion maps with segmental myocardial blood flow values.
The perfusion sequence will not produce additional quantitative perfusion maps.
All participants will receive vasodilator (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.
Eligibility Criteria
You may qualify if:
- male or female at age 35-85 years,
- presence of either of the following sign/symptom that led to a referral to stress cardiac magnetic resonance imaging:
- chest pain or anginal equivalent, or
- abnormal electrocardiogram with a suspicion of coronary artery disease
- 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
You may not qualify if:
- Acute myocardial infarction within the past 30 days prior to cardiac magnetic resonance imaging
- Confirmed diagnosis of any significant non-coronary cardiac conditions below:
- any severe-grade valvular heart disease,
- left ventricular ejection fraction \<40% from any known non-coronary causes,
- infiltrative cardiomyopathy,
- hypertrophic cardiomyopathy,
- pericardial disease with significant constriction, or
- active pregnancy,
- any competing conditions leading to an expected survival of \< 2 years
- contraindication to vasodilator (regadenoson or adenosine)
- metallic device or object that poses an magnetic resonance imaging safety hazard
- metallic device with a high likelihood of non-diagnostic cardiac magnetic resonance images
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of California San Francisco
San Francisco, California, 94107, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
St. Francis Hospital and Heart Center
Roslyn, New York, 11576, United States
Atrium Health - Sanger Heart & Vascular Institute
Charlotte, North Carolina, 28204, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Related Publications (8)
Pepine CJ, Anderson RD, Sharaf BL, Reis SE, Smith KM, Handberg EM, Johnson BD, Sopko G, Bairey Merz CN. Coronary microvascular reactivity to adenosine predicts adverse outcome in women evaluated for suspected ischemia results from the National Heart, Lung and Blood Institute WISE (Women's Ischemia Syndrome Evaluation) study. J Am Coll Cardiol. 2010 Jun 22;55(25):2825-32. doi: 10.1016/j.jacc.2010.01.054.
PMID: 20579539BACKGROUNDPatel MR, Peterson ED, Dai D, Brennan JM, Redberg RF, Anderson HV, Brindis RG, Douglas PS. Low diagnostic yield of elective coronary angiography. N Engl J Med. 2010 Mar 11;362(10):886-95. doi: 10.1056/NEJMoa0907272.
PMID: 20220183BACKGROUNDSammut EC, Villa ADM, Di Giovine G, Dancy L, Bosio F, Gibbs T, Jeyabraba S, Schwenke S, Williams SE, Marber M, Alfakih K, Ismail TF, Razavi R, Chiribiri A. Prognostic Value of Quantitative Stress Perfusion Cardiac Magnetic Resonance. JACC Cardiovasc Imaging. 2018 May;11(5):686-694. doi: 10.1016/j.jcmg.2017.07.022. Epub 2017 Nov 15.
PMID: 29153572BACKGROUNDKotecha T, Chacko L, Chehab O, O'Reilly N, Martinez-Naharro A, Lazari J, Knott KD, Brown J, Knight D, Muthurangu V, Hawkins P, Plein S, Moon JC, Xue H, Kellman P, Rakhit R, Patel N, Fontana M. Assessment of Multivessel Coronary Artery Disease Using Cardiovascular Magnetic Resonance Pixelwise Quantitative Perfusion Mapping. JACC Cardiovasc Imaging. 2020 Dec;13(12):2546-2557. doi: 10.1016/j.jcmg.2020.06.041. Epub 2020 Oct 1.
PMID: 33011115BACKGROUNDPatel AR, Kramer CM. Role of Cardiac Magnetic Resonance in the Diagnosis and Prognosis of Nonischemic Cardiomyopathy. JACC Cardiovasc Imaging. 2017 Oct;10(10 Pt A):1180-1193. doi: 10.1016/j.jcmg.2017.08.005.
PMID: 28982571BACKGROUNDRozanski A, Gransar H, Hayes SW, Friedman JD, Hachamovitch R, Berman DS. Comparison of long-term mortality risk following normal exercise vs adenosine myocardial perfusion SPECT. J Nucl Cardiol. 2010 Dec;17(6):999-1008. doi: 10.1007/s12350-010-9300-9. Epub 2010 Nov 13.
PMID: 21076898BACKGROUNDArai AE, Schulz-Menger J, Shah DJ, Han Y, Bandettini WP, Abraham A, Woodard PK, Selvanayagam JB, Hamilton-Craig C, Tan RS, Carr J, Teo L, Kramer CM, Wintersperger BJ, Harisinghani MG, Flamm SD, Friedrich MG, Klem I, Raman SV, Haverstock D, Liu Z, Brueggenwerth G, Santiuste M, Berman DS, Pennell DJ. Stress Perfusion Cardiac Magnetic Resonance vs SPECT Imaging for Detection of Coronary Artery Disease. J Am Coll Cardiol. 2023 Nov 7;82(19):1828-1838. doi: 10.1016/j.jacc.2023.08.046.
PMID: 37914512BACKGROUNDNayfeh M, Ahmed AI, Saad JM, Alahdab F, Al-Mallah M. The Role of Cardiac PET in Diagnosis and Prognosis of Ischemic Heart Disease: Optimal Modality Across Different Patient Populations. Curr Atheroscler Rep. 2023 Jul;25(7):351-357. doi: 10.1007/s11883-023-01107-0. Epub 2023 May 10.
PMID: 37162723BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 24, 2025
First Posted
March 3, 2025
Study Start
June 27, 2025
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
March 1, 2029
Last Updated
May 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share