Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy
NCT ID: NCT04990297
Last Updated: 2022-10-31
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
2500 participants
OBSERVATIONAL
2019-12-24
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. LV end-diastolic volume \>2SD from normal according to normograms corrected by body surface area (BSA) and age.
Exclusion Criteria
Coronary angiography, perfusion imaging Medical documentation that indicated the presence of ischemic heart disease An infarct pattern of late gadolinium enhancement on cardiac magnetic resonance studies and/or acute coronary syndrome or coronary revascularization during follow-up
2. Any evidence of hypertrophic cardiomyopathy, or moderate-to-severe valvular disease\[18\], or infiltrative disease (such as amyloidosis, sarcoidosis, Fabry disease)
3. Incessant arrhythmias
4. Inability to lie flat
5. Pregnancy
6. Contraindication to cardiac magnetic resonance including severe claustrophobia, defibrillators, pacemakers, certain types of intracranial aneurysm clips, intraocular metal, and Stage IV/V chronic kidney disease
7. Diabetes mellitus with end organ damage
8. Inability to provide informed consent.
ALL
No
Sponsors
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Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Minjie Lu
Vice Director of Magnetic Resonance Imaging
Principal Investigators
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Minjie Lu, PhD
Role: STUDY_CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Locations
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Fuwai Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Shah KS, Xu H, Matsouaka RA, Bhatt DL, Heidenreich PA, Hernandez AF, Devore AD, Yancy CW, Fonarow GC. Heart Failure With Preserved, Borderline, and Reduced Ejection Fraction: 5-Year Outcomes. J Am Coll Cardiol. 2017 Nov 14;70(20):2476-2486. doi: 10.1016/j.jacc.2017.08.074. Epub 2017 Nov 12.
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.
Stecker EC, Vickers C, Waltz J, Socoteanu C, John BT, Mariani R, McAnulty JH, Gunson K, Jui J, Chugh SS. Population-based analysis of sudden cardiac death with and without left ventricular systolic dysfunction: two-year findings from the Oregon Sudden Unexpected Death Study. J Am Coll Cardiol. 2006 Mar 21;47(6):1161-6. doi: 10.1016/j.jacc.2005.11.045. Epub 2006 Feb 23.
Rahimi K, Bennett D, Conrad N, Williams TM, Basu J, Dwight J, Woodward M, Patel A, McMurray J, MacMahon S. Risk prediction in patients with heart failure: a systematic review and analysis. JACC Heart Fail. 2014 Oct;2(5):440-6. doi: 10.1016/j.jchf.2014.04.008. Epub 2014 Sep 3.
Fukushima A, Milner K, Gupta A, Lopaschuk GD. Myocardial Energy Substrate Metabolism in Heart Failure : from Pathways to Therapeutic Targets. Curr Pharm Des. 2015;21(25):3654-64. doi: 10.2174/1381612821666150710150445.
Marwick TH, Shah SJ, Thomas JD. Myocardial Strain in the Assessment of Patients With Heart Failure: A Review. JAMA Cardiol. 2019 Mar 1;4(3):287-294. doi: 10.1001/jamacardio.2019.0052.
Ferreira VM, Schulz-Menger J, Holmvang G, Kramer CM, Carbone I, Sechtem U, Kindermann I, Gutberlet M, Cooper LT, Liu P, Friedrich MG. Cardiovascular Magnetic Resonance in Nonischemic Myocardial Inflammation: Expert Recommendations. J Am Coll Cardiol. 2018 Dec 18;72(24):3158-3176. doi: 10.1016/j.jacc.2018.09.072.
Gormeli CA, Ozdemir ZM, Kahraman AS, Yagmur J, Ozdemir R, Colak C. The evaluation of non-ischemic dilated cardiomyopathy with T1 mapping and ECV methods using 3T cardiac MRI. Radiol Med. 2017 Feb;122(2):106-112. doi: 10.1007/s11547-016-0701-y. Epub 2016 Oct 27.
Barison A, Del Torto A, Chiappino S, Aquaro GD, Todiere G, Vergaro G, Passino C, Lombardi M, Emdin M, Masci PG. Prognostic significance of myocardial extracellular volume fraction in nonischaemic dilated cardiomyopathy. J Cardiovasc Med (Hagerstown). 2015 Oct;16(10):681-7. doi: 10.2459/JCM.0000000000000275.
Inui K, Asai K, Tachi M, Yoshinaga A, Izumi Y, Kubota Y, Murai K, Tsukada YT, Amano Y, Kumita S, Shimizu W. Extracellular volume fraction assessed using cardiovascular magnetic resonance can predict improvement in left ventricular ejection fraction in patients with dilated cardiomyopathy. Heart Vessels. 2018 Oct;33(10):1195-1203. doi: 10.1007/s00380-018-1154-0. Epub 2018 Mar 20.
Vita T, Grani C, Abbasi SA, Neilan TG, Rowin E, Kaneko K, Coelho-Filho O, Watanabe E, Mongeon FP, Farhad H, Rassi CH, Choi YL, Cheng K, Givertz MM, Blankstein R, Steigner M, Aghayev A, Jerosch-Herold M, Kwong RY. Comparing CMR Mapping Methods and Myocardial Patterns Toward Heart Failure Outcomes in Nonischemic Dilated Cardiomyopathy. JACC Cardiovasc Imaging. 2019 Aug;12(8 Pt 2):1659-1669. doi: 10.1016/j.jcmg.2018.08.021. Epub 2018 Nov 15.
Other Identifiers
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CREATE
Identifier Type: -
Identifier Source: org_study_id
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