Cardiovascular Disease Clinical Trial
Official title:
A Clinical Trial to Identify Genetic Variations That Affect The Ability of Patients To Metabolize Drugs Through Metabolic Pathways 2C19, 2C9, 2D6, 3A4, 3A5, Factor II, Factor V, MTHFR and VKORC1
This observation will look at patient care decisions of the primary healthcare provider utilizing the results of the DNA testing of patients' metabolic pathways using 2C19, 2C9, 2D6, 3A4, Factor II, Factor V and MTHFR and VKORC1. Findings of the data collection will be published to optimize the benefits of pharmacogenomics testing and publish health outcomes.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | March 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult male or female patients age 18 or older 2. Prescribed at least one medication with in any of the metabolic pathways being assessed will be enrolled in the study. 3. Completed DNA testing for the pathways under review for this observation. Exclusion Criteria: 1. Anticipated life expectancy less than 1 month. 2. Employee of the investigator, with direct involvement in the proposed study or other studies under the direction of the investigator, as well as immediate family members or the employee or primary care provider. |
Observational Model: Case-Only, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Sevierville Foot and Ankle Clinic | Sevierville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Bracane Company | IFG Medical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify individual variations in metabolic pathways of 2C19, 2C9, 2D6, 3A4, 3A5, Factor II, Factor V, MTHFR and VKORC1 | Patients with variations in metabolic pathways of 2C19, 2C9, 2D6, 3A4, 3A5, Factor II, Factor V, MTHFR and VKORC1 that may inhibit the normal metabolism of medications that are metabolized through these pathways will be identified and care received observed for changes in healthcare plan. | 18 months | No |
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