Global Electrical Heterogeneity and Clinical Outcomes (GEHCO)
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| ClinicalTrials.gov Identifier: NCT03210883 |
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Recruitment Status :
Active, not recruiting
First Posted : July 7, 2017
Last Update Posted : August 28, 2019
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Sponsor:
Larisa Tereshchenko
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Larisa Tereshchenko, Oregon Health and Science University
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Brief Summary:
This retrospective multicenter cohort will validate an independent association of electrocardiographic (ECG) global electrical heterogeneity (GEH) measures with sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD, and will validate and re-calibrate GEH ECG risk score for prediction of sustained ventricular tachyarrhythmias and appropriate ICD therapies in systolic heart failure patients with primary prevention ICD.
| Condition or disease |
|---|
| Heart Failure Implantable Defibrillator User Ventricular Arrythmia |
| Study Type : | Observational |
| Actual Enrollment : | 10000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Global Electrical Heterogeneity and Clinical Outcomes |
| Actual Study Start Date : | July 1, 2017 |
| Estimated Primary Completion Date : | June 30, 2020 |
| Estimated Study Completion Date : | June 30, 2020 |
Primary Outcome Measures :
- Primary outcome: sustained VT/VF event with appropriate ICD therapy (either ATP or shock) [ Time Frame: up to 15 years ]Sustained ventricular tachyarrhythmia event with appropriate ICD therapy (either antitachycardia pacing or shock)
- Primary competing outcome: All-cause death without preceding sustained VT/VF with appropriate ICD therapy [ Time Frame: up to 15 years ]All-cause death without preceding sustained ventricular tachyarrhythmia with appropriate ICD therapy
Secondary Outcome Measures :
- sustained monomorphic ventricular tachycardia [ Time Frame: up to 15 years ]Sustained monomorphic ventricular tachycardia with appropriate ICD therapies (either antitachycardia pacing or ICD shock)
- sustained polymorphic ventricular tachycardia / ventricular fibrillation [ Time Frame: up to 15 years ]sustained polymorphic ventricular tachycardia or ventricular fibrillation with appropriate ICD therapies (either antitachycardia pacing or ICD shock)
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| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
retrospective records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications
Criteria
Inclusion Criteria:
- records of systolic heart failure patients with primary prevention ICDs/CRT-Ds implanted for routine clinical indications
Exclusion Criteria:
- absent baseline pre-implant digital ECG;
- missing data on clinical predictors and covariates;
- missing ICD programming data (including number of intervals to detect [NID] or time to detect, number of detection zones, heart rate for each detection zone, and anti-tachycardia pacing [ATP] programming);
- missing outcomes data.
- records of patients with inherited channelopathies (e.g. long QT syndrome, Brugada syndrome), inherited cardiomyopathies (e.g. hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), and congenital heart disease.
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): NCT03210883
Locations
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| University of Colorado | |
| Aurora, Colorado, United States, 80045 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| Veteran Administration Portland Healthcare System | |
| Portland, Oregon, United States, 97239 | |
Sponsors and Collaborators
Larisa Tereshchenko
American Heart Association
Investigators
| Principal Investigator: | Larisa G Tereshchenko, MD, PhD | Oregon Health and Science University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Larisa Tereshchenko, Associate Professor of Medicine, Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT03210883 |
| Other Study ID Numbers: |
STUDY00016754 |
| First Posted: | July 7, 2017 Key Record Dates |
| Last Update Posted: | August 28, 2019 |
| Last Verified: | August 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Heart Failure Heart Diseases Cardiovascular Diseases |