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

NCT02757742 | Completed DMC

• 1 other identifier: NICM-002-FW
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiomyopathy

Keywords

sudden cardiac death; ventricular arrhythmias; cardiopathy; late gadolinium enhancement

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (2)

• All-cause death(including cardiac death and non-cardiac death)

  six years

• Heart transplantation

  six years

Study Arms (1)

Non-ischemic cardiomyopathy

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

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chinese patients with non-ischemic cardiomyopathy

You may qualify if:

• 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%

You may not qualify if:

• 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 ；

Sponsors & Collaborators

• Fu Wai Hospital, Beijing, China: lead

Study Sites (1)

Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

Location

Related 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.

  PMID: 25092278 BACKGROUND

• 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.

  PMID: 25616815 BACKGROUND

• 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.

  PMID: 26037794 BACKGROUND

• 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.

  PMID: 26842111 BACKGROUND

• 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.

  PMID: 25761994 BACKGROUND

• 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.

  PMID: 26116301 BACKGROUND

• 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.

  PMID: 25428735 BACKGROUND

• 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.

  PMID: 26104916 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies; Death, Sudden, Cardiac; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaohan Fan, MD,PHD

  Fu Wai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated director, head of Cardiology,Principal Investigation, Clinical Professor

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 2, 2016
• Study Start: December 1, 2010
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

CN (1)