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Response to Medication Registry

13. mars 2019 oppdatert av: Intermountain Health Care, Inc.

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.

Studieoversikt

Status

Fullført

Forhold

Uønskede narkotikahendelser

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

196

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Forente stater
- Utah
  - Salt Lake City, Utah, Forente stater, 84143
    - LDS Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients from existing Intermountain Healthcare databases and registries who either have taken drugs that treat cardiovascular conditions or that have presented with cardiovascular symptoms that may be related to medication.

Beskrivelse

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

Exclusion Criteria:

There are no exclusion criteria for this registry.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Genetic and biomarker correlates with clinical response(s) to medication Tidsramme: 5 years	We will monitor clinical responses to medications for 5 years and look for genetic markers and biomarkers that correlate with these responses.	5 years

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Dosage adjustments Tidsramme: 5 years	We will monitor medication dosage adjustments for 5 years and look for genetic markers and biomarkers that correlate with these adjustments.	5 years
Beneficial responses Tidsramme: 5 years	We will monitor beneficial responses to medications for 5 years and look for genetic markers and biomarkers that correlate with these responses.	5 years
Adverse drug events Tidsramme: 5 years	We will monitor adverse drug events for 5 years and look for genetic markers and biomarkers that correlate with these events.	5 years
Drug interactions Tidsramme: 5 years	We will monitor drug interactions for 5 years and look for genetic markers and biomarkers that correlate with these interactions.	5 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Intermountain Health Care, Inc.

Etterforskere

Hovedetterforsker: John F Carlquist, PhD, LDS Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mars 2007

Primær fullføring (Faktiske)

1. september 2018

Studiet fullført (Faktiske)

1. desember 2018

Datoer for studieregistrering

Først innsendt

29. oktober 2015

Først innsendt som oppfylte QC-kriteriene