Response to Medication Registry

NCT ID: NCT02593916

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Study Completion Date

2018-12-31

Brief Summary

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To create a registry/database of patients who either have taken drugs that treat cardiovascular conditions or that have presented with cardiovascular symptoms that may be related to medication.

Detailed Description

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To create a registry/database of patients who either have taken drugs that treat cardiovascular conditions or that have presented with cardiovascular symptoms that may be related to medication. Potential enrollees are those receiving (presently or in the past) the medicine(s) of interest. Subjects will be identified from computerized Intermountain Healthcare records. Patients receiving a drug of interest, both with and without an ADE will be enrolled in approximately equal numbers. Outpatients will be contacted by mail and invited to participate. Interested subjects will be instructed to return the enclosed response card with their intent indicated. The registry coordinator will contact interested subjects and the project will be explained. Willing participants will be enrolled either in person or via mail with the assistance of the project coordinator. Persons presenting in person for enrollment will be given the choice of venipuncture or buccal swab for sample collection for DNA extraction. In all cases informed consent will be obtained before collecting samples.

Conditions

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Adverse Drug Events

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* The patient must be \> 18 years of age.
* The patient or legally authorized representative must sign a written informed consent, prior to sample collection, using a form that is approved by the local Institutional Review Board.
* The patient must have taken a medication of interest or have presented with a cardiovascular symptom possibly related to medication. The current medications of interest are as follows:

* ACE inhibitors
* ARBs
* Aldosterone Antagonists
* Alpha-Andrenergic Agonists
* Anticoagulants
* B-Type Natriuretic Peptides
* Beta-blockers
* Calcium Channel Blockers
* Cardiac Glycosides
* Antiarrhythmics
* Combination Drugs
* Diuretics
* Electrolyte/Mineral Replacements
* Lipid-lowering Medications
* Positive Inotropes
* Vasodilators/Nitrates
* Statins
* Antibiotics
* Anthrocyclines
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intermountain Health Care, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John F Carlquist, PhD

Role: PRINCIPAL_INVESTIGATOR

LDS Hospital

Locations

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LDS Hospital

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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128024

Identifier Type: -

Identifier Source: org_study_id

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