Genetic Basis of Pacing-induced Cardiomyopathy
Sponsor
The Guthrie Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT03317964
Collaborator
(none)
170
1
74.5
2.3
Study Details
Study Description
Brief Summary
The purpose of this study is to collect a saliva sample from patients with a pacemaker to study genes involved in cardiomyopathy, a condition where the heart muscle is abnormal.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
DNA will be extracted from the saliva to test for changes in genes related to cardiomyopathy.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
170 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Genetic Basis of Pacing-Induced Cardiomyopathy
Actual Study Start Date
:
Oct 16, 2017
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Dec 31, 2023
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Saliva - cardiomyopathy Saliva sample for genetic testing from subjects who developed cardiomyopathy |
Other: Saliva sample
Extract sample of saliva only once
|
Saliva - no cardiomyopathy Saliva sample for genetic testing from subjects who do not have cariomyopathy |
Other: Saliva sample
Extract sample of saliva only once
|
Outcome Measures
Primary Outcome Measures
- Number of participants with genotype frequency [through study completion, an average of 1 year]
Number of participants with genotype frequency based on genetic testing of saliva samples
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients who have been assessed for cardiomyopathy
Exclusion Criteria:
- Patients who do not have adequate follow up care to determine if they do or do not have cardiomyopathy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Robert Packer Hospital | Sayre | Pennsylvania | United States | 18840 |
Sponsors and Collaborators
- The Guthrie Clinic
Investigators
- Principal Investigator: Pramod Deshmukh, MD, The Guthrie Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
The Guthrie Clinic
ClinicalTrials.gov Identifier:
NCT03317964
Other Study ID Numbers:
- 1706-34
First Posted:
Oct 23, 2017
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: