Ischemic Heart Disease (IHD)SPINS2NCT06854458
The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study
A study testing Quantitative Myocardial Blood Flow Evaluation, Qualitative Myocardial Blood Flow Evaluation and Gadavist in people with Ischemic Heart Disease (IHD) and Cardiac Magnetic Resonance Imaging, run by Brigham and Women's Hospital at 13 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Ischemic Heart Disease (IHD), Cardiac Magnetic Resonance Imaging, Myocardial Blood Flow
- What is being tested?
- Quantitative Myocardial Blood Flow Evaluation, Qualitative Myocardial Blood Flow Evaluation and Gadavist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 13 sitesUnited States
- Study dates
- 27 Jun 2025to Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bobby Heydari, MD, MPH contact
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Raymond Y Kwong, MD, MPH, 857-307-1960, rykwong@bwh.harvard.edu
Raymond Y. Kwong, MD, MPH
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Connie Tsao, MD, MPH, (617) 667-8800, ctsao1@bidmc.harvard.edu
Connie Tsao, MD, MPH
- Recruiting
Atrium Health - Sanger Heart & Vascular Institute
Charlotte, North Carolina, 28204
Heather Gaines, 704-468-3201, Heather.Gaines@advocatehealth.org
Zariyat Mannan, MD
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Cristiane Singulane, 000-000-0000, FQE4TZ@uvahealth.org
Amit Patel, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Danielle Burton, 216-636-8883, burtond7@ccf.org
Deborah Kwon, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Debbie Scandling, 000-000-0000, Debbie.Scandling@osumc.edu
Matthew Tong, DO
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Mariya Potapenko, 346-238-5103, mmpotapenko@houstonmethodist.org
Faisal Nabi, MD
- Recruiting
UofL Health - Heart Hospital
Louisville, Kentucky, 40202
Gurnoor Singh, MD, 443-713-0675, g0sing16@louisville.edu
Shahab Ghafghazi, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Reynolds Cassandra, 615-875-9854, cassandra.f.reynolds@vumc.org
Bruno Lima, MD, PhD
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Caleb Bridgwater, 804-628-8527, Caleb.Bridgwater@vcuhealth.org
Cory Trankle, MD
- Recruiting
St. Francis Hospital and Heart Center
Roslyn, New York, 11576
Elizabeth Haag, 516-562-6790, elizabeth.haag@chsli.org
Jane Cao, MD, MPH
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Kyle Berg, 801-587-0326, kyle.berg@hsc.utah.edu
Andrew Arai, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94107
Katie DeSutter, 559-696-1926, Katie.Desutter@ucsf.edu
Michael Salerno, MD, PhD
About this study
Official title: The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States (SPINS2) Study
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.
Read the 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.
- Being tested
- Quantitative Myocardial Blood Flow Evaluation, Qualitative Myocardial Blood Flow Evaluation, Gadavist, Vasodilator, Blood draw for the laboratory assessment
- Keywords
- Myocardial Blood Flow, Cardiac Magnetic Resonance, Quantitative perfusion, Cardiovascular Outcomes
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Myocardial Blood Flow EvaluationDiagnostic test
Also called New Myocardial Blood Flow Evaluation
The perfusion sequence will produce on-the-fly additional quantitative perfusion maps with segmental myocardial blood flow values.
Qualitative Myocardial Blood Flow EvaluationDiagnostic test
Also called Standard Myocardial Blood Flow Evaluation
The perfusion sequence will not produce additional quantitative perfusion maps.
GadavistDrug
Also called Gadobutrol
Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
VasodilatorDrug
Also called stress vasodilator
All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).
Blood draw for the laboratory assessmentDiagnostic test
A single (7-10 ml tube) whole blood sample will be collected from each patient for processing of blood biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Standard Myocardial Blood Flow Evaluation | Active comparator | Qualitative stress cardiac magnetic resonance imaging only. Receives: Diagnostic Test: Qualitative Myocardial Blood Flow Evaluation; Drug: Gadavist; Drug: Vasodilator; Diagnostic Test: Blood draw for the laboratory assessment |
| New Myocardial Blood Flow Evaluation | Experimental | Quantitative + Qualitative stress cardiac magnetic resonance imaging. Receives: Diagnostic Test: Quantitative Myocardial Blood Flow Evaluation; Drug: Gadavist; Drug: Vasodilator; Diagnostic Test: Blood draw for the laboratory assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From cardiac magnetic resonance imaging to the end of follow-up in 24 months
Secondary outcomes (2)
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).
Measured: From cardiac magnetic resonance imaging to the end of follow-up in 24 months
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.
Measured: From cardiac magnetic resonance imaging to the end of follow-up in 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start27 Jun 2025
- Primary completionJan 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart Disease (IHD)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Y. Kwong, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854458
- Sponsor's protocol ID
- 2024P003457
- Acronym
- SPINS2
- Status last verified
- Feb 2026
- First submitted
- 24 Feb 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20579539Patel 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.
PubMed 20220183Sammut 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.
PubMed 29153572Kotecha 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.
PubMed 33011115Patel 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.
PubMed 28982571Rozanski 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.
PubMed 21076898Arai 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.
PubMed 37914512Nayfeh 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.
PubMed 37162723