Wiser Choices in Acute Myocardial Infarction

March 18, 2016 updated by: Nilay D. Shah, Mayo Clinic
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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Saint Marys Hospital, Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Decision Aid
Patients in this arm will discuss medications to help the heart heal after a heart attack with the clinician and the help of the acute myocardial infarction (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.
Active Comparator: Usual Care
Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.
Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increases adherence to cardiac medications with proven benefits
Time Frame: 6 months
6 months
Reduces patients' decisional conflict (increase patient decisional quality)
Time Frame: During hospital stay
During hospital stay
Decreases rehospitalization rates and death
Time Frame: 5 weeks and 6 months
5 weeks and 6 months
Increase patient knowledge of medication to help the heart heal
Time Frame: During hospital stay
During hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Henry Ting, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Estimate)

March 21, 2016

Last Update Submitted That Met QC Criteria

March 18, 2016

Last Verified

March 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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