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

Cardiomyopathy Clinical Trial

Official title:

A Quantitive Late Gadolinium Enhancement(LGE) Mass Based Tool for Risk Prediction of Sudden Cardiac Death(SCD) in Non-ischemic Cardiomyopathy(NICM) Patients With Severe Cardiac Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02757742
• Other study ID #: NICM-002-FW
• Status: Completed
• Phase: N/A
• First received: April 26, 2016
• Last updated: August 9, 2016
• Start date: December 2010
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Fu Wai Hospital, Beijing, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 65 Years

Eligibility

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 ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Death, Sudden, Cardiac

Locations

Country	Name	City	State
China	Fu Wai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fu Wai Hospital, Beijing, China

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sudden cardiac death(SCD)	SCD was defined as cardiac death occured in a short time period (2 hour of symptom), which were assessed by two separated doctors from the central laboratory.	Six years	No
Primary	Aborted cardiac arrest	Aborted cardiac arrest were defined as patients with ventricular tachycardia, ventricular fibrillation or sudden cardiac death were saved by cardio-pulmonary resuscitation and electric defibrillation.	Six years	No
Primary	Documented appropriate ICD therapy for ventricular tachycardia	Participants with ICD or CRTD implanted came to the clinic every 6 months for device's programming control. Shock related events were analyzed by two separated experienced electrophysiology doctor(more than 5 years),to identify if the shock is delivered by sustained ventricular tachycardia, ventricular fibrillation and sudden cardiac death.	Six years	No
Primary	Documented appropriate ICD therapy for ventricular fibrillation	Participants with ICD or CRTD implanted came to the clinic every 6 months for device's programming control. Shock related events were analyzed by two separated experienced electrophysiology doctor(more than 5 years),to identify if the shock is delivered by sustained ventricular tachycardia, ventricular fibrillation and sudden cardiac death.	Six years	No
Secondary	All-cause death(including cardiac death and non-cardiac death)	Participants were followed up every 6 months and the survival status of participants were documented(death or not, if the patient was dead, time of death and cause of death were documented)	six years	No
Secondary	Heart transplantation	Participants were followed up every 6 months, if the patients received heart transplantation, the follow ups were terminated and time for heart transplantation were documented.	six years	No