Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 65 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

China Inherited Ventricular Arrhythmias Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03880708
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborators:
Renmin Hospital of Wuhan University
The First Affiliated Hospital with Nanjing Medical University
Second Affiliated Hospital of Nanchang University
Sir Run Run Shaw Hospital
West China Hospital
Beijing Anzhen Hospital
General Hospital of Shenyang Military Region
Xuzhou Central Hospital
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

Brief Summary:
This is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant inherited ventricular arrhythmias, including Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) and Catecholaminergic polymorphic ventricular tachycardia(CPVT). 500 participants will be recruited from 10 centers in China, with clinical data to be abstracted from medical records, and blood samples to be collected for finding related genes and promising risk indicators. The follow-up should be made every 6 months.

Condition or disease
Ventricular Arrythmia

Detailed Description:

In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition, mainstream treatment relies on implantable devices and medication. China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting of several interrelated studies, with the aim of building a risk stratification as well as an efficient and economic strategy for early prevention and treatment.

Inherited Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at exploring the correlation between genotype and phenotype for inherited structural ventricular arrhythmias, thus helping molecular diagnosis and risk stratification of these conditions. 500 patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia centers distributed in 6 areas in China. At study entry, participants will be interviewed and asked to sign the informed consent. Demographic characteristics, medical history, clinical features, laboratory tests, imaging pictures, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well-trained staffs. At the same time, blood samples will be collected to detect biological markers, like genes, inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6 mouths about condition of arrhythmia, medication, clinical events, etc.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: China Inherited Ventricular Arrhythmias Registry, a Multicenter, Observational and Prospective Study
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : October 24, 2022
Estimated Study Completion Date : October 24, 2027





Primary Outcome Measures :
  1. sustained tachycardia/ ventricular fibrillation or sudden cardiac death [ Time Frame: 5 years ]
    event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death


Secondary Outcome Measures :
  1. episodes of arrhythmia [ Time Frame: 5 years ]
    type of arrhythmia, the amount of episodes, duration, unstable hemodynamics, treatment

  2. all-cause death [ Time Frame: 5 years ]
    exclude accidents, like trauma, drowning


Biospecimen Retention:   Samples With DNA
blood sample will be collected from enrolled participants to detect biomarkers, like genes, inflammatory factors ,etc.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In 10 major arrhythmia centers distributed in 6 areas in China, 500 patients satisfying the inclusion criteria will be enrolled consecutively
Criteria

Inclusion Criteria:

  • diagnosed as Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) or Catecholaminergic polymorphic ventricular tachycardia(CPVT).

Exclusion Criteria:

  • patients were enrolled by other clinical trials.

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): NCT03880708


Contacts
Layout table for location contacts
Contact: Yan YAO, MD,PhD +86-13901121319 ianyao@263.net.cn
Contact: Shangyu LIU, MD +86-18800161355 liushangyu_yu_fw@163.com

Locations
Layout table for location information
China, Beijing
China National Center for Cardiovascular Diseases Recruiting
Beijing, Beijing, China, 100037
Contact: Yan YAO, MD, PhD    +86-13901121319    ianyao@263.net.cn   
Contact: Shangyu LIU, MD    +86-18800161355    liushangyu_fw@163.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Renmin Hospital of Wuhan University
The First Affiliated Hospital with Nanjing Medical University
Second Affiliated Hospital of Nanchang University
Sir Run Run Shaw Hospital
West China Hospital
Beijing Anzhen Hospital
General Hospital of Shenyang Military Region
Xuzhou Central Hospital
First Affiliated Hospital, Sun Yat-Sen University
Investigators
Layout table for investigator information
Study Chair: Yan YAO, MD, PhD China National Center for Cardiovascular Diseases

Layout table for additonal information
Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03880708     History of Changes
Other Study ID Numbers: 2017-950-2
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by China National Center for Cardiovascular Diseases:
brugada syndrome
long QT syndrome
short QT syndrome
early repolarization syndrome
catecholaminergic polymorphic ventricular tachycardia