Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Response to Medication Registry

13. marts 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Uønskede lægemiddelhændelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

196

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84143
    - LDS Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	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	Foranstaltningsbeskrivelse	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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Intermountain Health Care, Inc.

Efterforskere

Ledende efterforsker: John F Carlquist, PhD, LDS Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2007

Primær færdiggørelse (Faktiske)

1. september 2018

Studieafslutning (Faktiske)

1. december 2018

Datoer for studieregistrering

Først indsendt

29. oktober 2015

Først indsendt, der opfyldte QC-kriterier