Quantitive LGE Mass in Prediction of SCD in NICM Patients With Severe Cardiac Dysfunction

NCT ID: NCT02757742

Last Updated: 2016-08-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 356 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2016-08-31

Brief Summary

The purpose of this study is to establish a quantitative LGE mass based scoring system (including LGE mass on cardiac magnetic resonance , clinical features, specific medical histories, et al) for risk prediction of sudden cardiac death in non-ischemic dilated cardiomyopathy patients with reduced left ventricular ejection fraction

Detailed Description

This is a Single-centered, Prospective, Observational Study. The study design included two phases. In Phase I, the investigators enrolled a set of consecutive patients with non-ischemic cardiomyopathy who performed contrast-enhanced cardiac magnetic resonance at baseline and had severe cardiac dysfunction (defined as cardiac magnetic resonance LVEF equal or less than 35% ) in FuWai Hospital from 2010 to 2013. The investigators collect patients' clinical baseline data and cardiac magnetic resonance specific data(Late gadolinium enhancement mass). All patients were followed up every six month by phone or clinical visits. The primary endpoint was composite of sudden cardiac death(SCD), ventricular arrhythmias(VAs) and SCD/VAs related Implantable Cardioverter defibrillator or cardiac resynchronization therapy-cardioverter defibrillator(ICD/CRTD) shock. The investigators plan to establish a quantitative LGE mass based model (including LGE mass on cardiac magnetic resonance, clinical features, specific medical histories, et al) for risk prediction of sudden cardiac death by analysing the phase I data(1-year model and 3-year model). In Phase II,the investigators will enroll another group of non-ischemic cardiomyopathy(NICM) patients from 2014 to 2015 to testify the risk prediction model(1-year model) the investigators have constructed in phase I. The investigators aim to find the real high risk NICM patients that may suffer from SCD or VAs in those with severe cardiac dysfunction.

Conditions

Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-ischemic cardiomyopathy

Non-ischemic cardiomyopathy patients with baseline cardiac magnetic resonance LVEF≤35%

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Non-ischemic cardiomyopathy patients receiving optimal medical treatment for 3 months; Age range from 10 years to 65 years old； Baseline cardiac magnetic resonance LVEF≤35%

Exclusion Criteria

• Known associated obstructive coronary Heart disease（including history of myocardial infarction or acute coronary event）； valvular heart disease； malignant carcinoma ； hypertensive heart disease； severe liver or kidney dysfunction ； plan to receiving heart transplantation ； patients refuse to or cannot receive cardiac magnetic resonance ； patients refuse to be followed up ；

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fu Wai Hospital, Beijing, China

OTHER

Sponsor Role: lead

Responsible Party

Fan Xiaohan

Associated director, head of Cardiology,Principal Investigation, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaohan Fan, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Fu Wai Hospital

Locations

Fu Wai Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Chan RH, Maron BJ, Olivotto I, Pencina MJ, Assenza GE, Haas T, Lesser JR, Gruner C, Crean AM, Rakowski H, Udelson JE, Rowin E, Lombardi M, Cecchi F, Tomberli B, Spirito P, Formisano F, Biagini E, Rapezzi C, De Cecco CN, Autore C, Cook EF, Hong SN, Gibson CM, Manning WJ, Appelbaum E, Maron MS. Prognostic value of quantitative contrast-enhanced cardiovascular magnetic resonance for the evaluation of sudden death risk in patients with hypertrophic cardiomyopathy. Circulation. 2014 Aug 5;130(6):484-95. doi: 10.1161/CIRCULATIONAHA.113.007094.

Reference Type: BACKGROUND

PMID: 25092278 (View on PubMed)

Dou K, Zhang D, Xu B, Yang Y, Yin D, Qiao S, Wu Y, Yan H, You S, Wang Y, Wu Z, Gao R, Kirtane AJ. An angiographic tool for risk prediction of side branch occlusion in coronary bifurcation intervention: the RESOLVE score system (Risk prEdiction of Side branch OccLusion in coronary bifurcation interVEntion). JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):39-46. doi: 10.1016/j.jcin.2014.08.011.

Reference Type: BACKGROUND

PMID: 25616815 (View on PubMed)

Zhang S, Singh B, Rodriguez DA, Chasnoits AR, Hussin A, Ching CK, Huang D, Liu YB, Cerkvenik J, Willey S, Kim YH. Improve the prevention of sudden cardiac arrest in emerging countries: the Improve SCA clinical study design. Europace. 2015 Nov;17(11):1720-6. doi: 10.1093/europace/euv103. Epub 2015 Jun 1.

Reference Type: BACKGROUND

PMID: 26037794 (View on PubMed)

Zhang S. Sudden cardiac death in China: current status and future perspectives. Europace. 2015 Oct;17 Suppl 2:ii14-8. doi: 10.1093/europace/euv143.

Reference Type: BACKGROUND

PMID: 26842111 (View on PubMed)

Tateishi E, Noguchi T, Goto Y, Morita Y, Ishibashi-Ueda H, Yamada N, Kanzaki H, Nishimura K, Miyamoto Y, Anzai T, Ogawa H, Yasuda S. Prognostic impact of blood pressure response plus gadolinium enhancement in dilated cardiomyopathy. Heart. 2015 May 15;101(10):774-80. doi: 10.1136/heartjnl-2014-307007. Epub 2015 Mar 11.

Reference Type: BACKGROUND

PMID: 25761994 (View on PubMed)

Duan X, Li J, Zhang Q, Zeng Z, Luo Y, Jiang J, Chen Y. Prognostic value of late gadolinium enhancement in dilated cardiomyopathy patients: a meta-analysis. Clin Radiol. 2015 Sep;70(9):999-1008. doi: 10.1016/j.crad.2015.05.007. Epub 2015 Jun 23.

Reference Type: BACKGROUND

PMID: 26116301 (View on PubMed)

Kang Y, Cheng L, Cui J, Li L, Qin S, Su Y, Mao J, Gong X, Chen H, Pan C, Shen X, He B, Shu X. A new score system for predicting response to cardiac resynchronization therapy. Cardiol J. 2015;22(2):179-87. doi: 10.5603/CJ.a2014.0089. Epub 2014 Nov 27.

Reference Type: BACKGROUND

PMID: 25428735 (View on PubMed)

Sakamoto N, Sato N, Talib AK, Sugiyama E, Minoshima A, Tanabe Y, Fujino T, Takeuchi T, Akasaka K, Saijo Y, Kawamura Y, Hasebe N. Late Gadolinium Enhancement on Cardiac MRI Correlates with QT Dynamicity Represented by QT/RR Relationship in Patients with Ventricular Arrhythmias. Ann Noninvasive Electrocardiol. 2016 Mar;21(2):126-35. doi: 10.1111/anec.12280. Epub 2015 Jun 24.

Reference Type: BACKGROUND

PMID: 26104916 (View on PubMed)

Other Identifiers

NICM-002-FW

Identifier Type: -

Identifier Source: org_study_id