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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
Are there results?
Not yet: the study is under way

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,
Show all 12Show fewer
  • 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.

Raymond Y Kwong, MD, MPH contact

857-307-1960

rykwong@bwh.harvard.edu

Bobby Heydari, MD, MPH contact

bheydari@bwh.harvard.edu

13 sites in 1 country

United States13 sites, 13 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

    Recruiting

Other trials in United States

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 groups in NCT06854458
Study groupRoleWhat they receive
Standard Myocardial Blood Flow EvaluationActive comparatorQualitative 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 EvaluationExperimentalQuantitative + 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.

  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.

    Measured: From cardiac magnetic resonance imaging to the end of follow-up in 24 months

Secondary outcomes (2)

  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).

    Measured: 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.

    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.

  1. First posted3 Mar 2025
  2. Study start27 Jun 2025
  3. Primary completionJan 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

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)
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 20579539

  • Patel 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 20220183

  • Sammut 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 29153572

  • Kotecha 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 33011115

  • Patel 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 28982571

  • Rozanski 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 21076898

  • Arai 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 37914512

  • Nayfeh 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Raymond Y Kwong, MD, MPH (857-307-1960, rykwong@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary composite outcome of major cardiovascular adverse events (MACE) (time frame: From cardiac magnetic resonance imaging to the end of follow-up in 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06854458, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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