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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00888537
Other study ID # 09-000748
Secondary ID
Status Completed
Phase N/A
First received April 24, 2009
Last updated June 10, 2015
Start date March 2009
Est. completion date June 2011

Study information

Verified date June 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Patients who are hospitalized because of a heart attack are prescribed a number of medicines to help the heart heal. The investigators will examine different ways in which clinicians share information about those treatment options with patients and the impact that this can have on patients' choices and health.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Between the ages of 18 and 90

- Hospitalized at Saint Marys Hospital

- A primary diagnosis of AMI,

- Have heart rate, blood pressure, troponin and creatinine measurements,

- There is an intention to offer treatment medications

- Are able and willing to provide informed consent

Exclusion Criteria:

- Have not had a myocardial infarction

- Have significant cognitive, visual impairment,

- Non-English speaker

- Have a Do Not Intubate/Do Not Resuscitate (DNI/DNR) status

- Will be discharged to a nursing home

- AMI is not the presumptive diagnosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Other:
AMI Choice Decision Aid
The decision aid describes the risk of dying in the first six months following a heart attack without and with taking a bundle of medications to help the heart heal.
Usual Care
Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.

Locations

Country Name City State
United States Saint Marys Hospital, Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Increases adherence to cardiac medications with proven benefits 6 months No
Primary Reduces patients' decisional conflict (increase patient decisional quality) During hospital stay No
Primary Decreases rehospitalization rates and death 5 weeks and 6 months No
Primary Increase patient knowledge of medication to help the heart heal During hospital stay No
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