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

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ClinicalTrials.gov Identifier: NCT02757742
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Fan Xiaohan, Fu Wai Hospital, Beijing, China

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

Condition or disease
Cardiomyopathy

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.

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Study Type : Observational
Actual Enrollment : 356 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : December 2010
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

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



Primary Outcome Measures :
  1. Sudden cardiac death(SCD) [ Time Frame: Six years ]
    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.

  2. Aborted cardiac arrest [ Time Frame: Six years ]
    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.

  3. Documented appropriate ICD therapy for ventricular tachycardia [ Time Frame: Six years ]
    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.

  4. Documented appropriate ICD therapy for ventricular fibrillation [ Time Frame: Six years ]
    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.


Secondary Outcome Measures :
  1. All-cause death(including cardiac death and non-cardiac death) [ Time Frame: six years ]
    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)

  2. Heart transplantation [ Time Frame: six years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chinese patients with non-ischemic cardiomyopathy
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 ;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757742


Locations
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China, Beijing
Fu Wai Hospital
Beijing, Beijing, China, 100037
Sponsors and Collaborators
Fu Wai Hospital, Beijing, China
Investigators
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Principal Investigator: Xiaohan Fan, MD,PHD Fu Wai Hospital

Publications:

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Responsible Party: Fan Xiaohan, Associated director, head of Cardiology,Principal Investigation, Clinical Professor, Fu Wai Hospital, Beijing, China
ClinicalTrials.gov Identifier: NCT02757742     History of Changes
Other Study ID Numbers: NICM-002-FW
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Keywords provided by Fan Xiaohan, Fu Wai Hospital, Beijing, China:
sudden cardiac death
ventricular arrhythmias
cardiopathy
late gadolinium enhancement
Additional relevant MeSH terms:
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Cardiomyopathies
Heart Diseases
Cardiovascular Diseases