Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

NCT ID: NCT04990297

Last Updated: 2022-10-31

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-24

Study Completion Date

2031-12-31

Brief Summary

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Dilated cardiomyopathy (DCM) is an increasingly recognized cause of morbidity and mortality with heterogenous etiologies (eg, genetic, environment) and clinical manifestations, characterized by left ventricular (LV) systolic dysfunction and LV or biventricular dilation. Previous publications reported the three-year treated mortality rates remain high at 12%-20% and a reported 5-year mortality rate up to 50%, with death resulting from ventricular arrhythmia leading to sudden cardiac death (SCD) or advanced heart failure (HF). With large fields of view and high spatial resolution, Cardiac magnetic resonance (CMR) is the reference standard for assessing cardiac mass, volume, and function. CMR also provides non noninvasive characterization of the myocardium benefiting to differential diagnosis and risk stratification.

Detailed Description

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Conditions

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Dilated Cardiomyopathy Single-center Study

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. reduced left ventricular ejection fraction (LVEF\<50%)
2. LV end-diastolic volume \>2SD from normal according to normograms corrected by body surface area (BSA) and age.

Exclusion Criteria

1. Any evidence indicating the presence of ischemic heart disease:

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Minjie Lu

Vice Director of Magnetic Resonance Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Minjie Lu, PhD

Role: CONTACT

+86-10-88396941

Facility Contacts

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Minjie Lu, PhD

Role: primary

+86 10 88398175

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.

Reference Type RESULT
PMID: 29141781 (View on PubMed)

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.

Reference Type RESULT
PMID: 27207191 (View on PubMed)

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.

Reference Type RESULT
PMID: 16545646 (View on PubMed)

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.

Reference Type RESULT
PMID: 25194291 (View on PubMed)

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.

Reference Type RESULT
PMID: 26166604 (View on PubMed)

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.

Reference Type RESULT
PMID: 30810702 (View on PubMed)

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.

Reference Type RESULT
PMID: 30545455 (View on PubMed)

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.

Reference Type RESULT
PMID: 27785679 (View on PubMed)

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.

Reference Type RESULT
PMID: 26090916 (View on PubMed)

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.

Reference Type RESULT
PMID: 29560528 (View on PubMed)

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.

Reference Type RESULT
PMID: 30448130 (View on PubMed)

Other Identifiers

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CREATE

Identifier Type: -

Identifier Source: org_study_id

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