The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study (SPINS2)

June 1, 2026 updated by: Raymond Y. Kwong, MD, Brigham and Women's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Michael Salerno, MD, PhD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • UofL Health - Heart Hospital
        • Contact:
        • Principal Investigator:
          • Shahab Ghafghazi, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
        • Principal Investigator:
          • Raymond Y. Kwong, MD, MPH
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Connie Tsao, MD, MPH
    • New York
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital and Heart Center
        • Contact:
        • Principal Investigator:
          • Jane Cao, MD, MPH
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Atrium Health - Sanger Heart & Vascular Institute
        • Contact:
        • Principal Investigator:
          • Zariyat Mannan, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Principal Investigator:
          • Deborah Kwon, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Contact:
        • Principal Investigator:
          • Matthew Tong, DO
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Bruno Lima, MD, PhD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Faisal Nabi, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Amit Patel, MD
        • Contact:
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Cory Trankle, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Myocardial Blood Flow Evaluation
Qualitative stress cardiac magnetic resonance imaging only.
Diagnostic test: Qualitative Myocardial Blood Flow Evaluation
The perfusion sequence will not produce additional quantitative perfusion maps.
Other Names:
  • Standard Myocardial Blood Flow Evaluation
Drug: Gadavist
Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
Other Names:
  • Gadobutrol
Drug: Vasodilator
All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).
Other Names:
  • stress vasodilator
Diagnostic test: Blood draw for the laboratory assessment
A single (7-10 ml tube) whole blood sample will be collected from each patient for processing of blood biomarkers.
Experimental: New Myocardial Blood Flow Evaluation
Quantitative + Qualitative stress cardiac magnetic resonance imaging.
Drug: Gadavist
Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
Other Names:
  • Gadobutrol
Drug: Vasodilator
All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).
Other Names:
  • stress vasodilator
Diagnostic test: Blood draw for the laboratory assessment
A single (7-10 ml tube) whole blood sample will be collected from each patient for processing of blood biomarkers.
Diagnostic test: Quantitative Myocardial Blood Flow Evaluation
The perfusion sequence will produce on-the-fly additional quantitative perfusion maps with segmental myocardial blood flow values.
Other Names:
  • New Myocardial Blood Flow Evaluation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure-related complications
Time Frame: 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).
From cardiac magnetic resonance imaging to the end of follow-up in 24 months
Cost outcomes for Comparative Cost-effectiveness
Time Frame: 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.
From cardiac magnetic resonance imaging to the end of follow-up in 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024P003457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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