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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-ischemic cardiomyopathy | Non-ischemic cardiomyopathy patients with baseline cardiac magnetic resonance LVEF≤35% |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Heart transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese patients with non-ischemic cardiomyopathy
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| Name | Affiliation | Role |
|---|---|---|
| Xiaohan Fan, MD,PHD | Fu Wai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Wai Hospital | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25092278 | Background | 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. | |
| 25616815 |
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| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D016757 | Death, Sudden, Cardiac |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
| D003643 | Death |
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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 |
| 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. |
| 26037794 | 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. |
| 26842111 | 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. |
| 25761994 | 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. |
| 26116301 | 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. |
| 25428735 | 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. |
| 26104916 | 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. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |