The Multicenter Stress Cardiac Magnetic Resonance Quantitative Perfusion Imaging in the United States Study
NCT ID: NCT06854458
Last Updated: 2025-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2025-06-27
2029-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Standard Myocardial Blood Flow Evaluation
Qualitative stress cardiac magnetic resonance imaging only.
Qualitative Myocardial Blood Flow Evaluation
The perfusion sequence will not produce additional quantitative perfusion maps.
Gadavist
Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
Vasodilator
All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).
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.
New Myocardial Blood Flow Evaluation
Quantitative + Qualitative stress cardiac magnetic resonance imaging.
Quantitative Myocardial Blood Flow Evaluation
The perfusion sequence will produce on-the-fly additional quantitative perfusion maps with segmental myocardial blood flow values.
Gadavist
Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
Vasodilator
All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).
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.
Interventions
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Quantitative 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 Evaluation
The perfusion sequence will not produce additional quantitative perfusion maps.
Gadavist
Participants will receive Gadavist 0.05 mmol/kg dose for each stress and rest perfusion imaging (total dose of 0.1 mmol/kg).
Vasodilator
All participants will receive vasodilator (regadenoson or adenosine depending on local site practice).
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
35 Years
85 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Raymond Y. Kwong, MD
Principal Investigator
Locations
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University of California San Francisco
San Francisco, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2024P003457
Identifier Type: -
Identifier Source: org_study_id
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