- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00888537
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
Conditions
Intervention / Treatment
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
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Minnesota
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Rochester, Minnesota, United States, 55905
- Saint Marys Hospital, Mayo Clinic
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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 |
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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.
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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.
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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.
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Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increases adherence to cardiac medications with proven benefits
Time Frame: 6 months
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6 months
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Reduces patients' decisional conflict (increase patient decisional quality)
Time Frame: During hospital stay
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During hospital stay
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Decreases rehospitalization rates and death
Time Frame: 5 weeks and 6 months
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5 weeks and 6 months
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Increase patient knowledge of medication to help the heart heal
Time Frame: During hospital stay
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During hospital stay
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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.
General Publications
- Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
- Branda ME, Kunneman M, Meza-Contreras AI, Shah ND, Hess EP, LeBlanc A, Linderbaum JA, Nelson DM, Mc Donah MR, Sanvick C, Van Houten HK, Coylewright M, Dick SR, Ting HH, Montori VM. Shared Decision-Making for Patients Hospitalized with Acute Myocardial Infarction: A Randomized Trial. Patient Prefer Adherence. 2022 Jun 1;16:1395-1404. doi: 10.2147/PPA.S363528. eCollection 2022.
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-000748
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.
Clinical Trials on Acute Myocardial Infarction
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Henry Ford Health SystemAbiomed Inc.Enrolling by invitationAcute Myocardial Infarction | Cardiogenic Shock | STEMI | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial Infarction | NSTEMI | Acute Myocardial Infarction With ST Elevation | Acute Myocardial Infarction of Right Ventricle (Disorder) | Acute Myocardial Infarction of Left VentricleUnited States
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Jordan Collaborating Cardiology GroupCardiovascular Academy GroupTerminatedTriggers of Acute Myocardial Infarction | Time of Onset of Acute Myocardial Infarction | Long-term Prognosis After Acute Myocardial InfarctionJordan
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Recardio, Inc.CompletedAcute Myocardial Infarction | STEMI - ST Elevation Myocardial Infarction | Acute Myocardial IschemiaNetherlands, Hungary, Austria, Poland, Belgium
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Medical Center of South ArkansasWithdrawnAcute Coronary Syndrome | Acute ST Segment Elevation Myocardial InfarctionUnited States
-
Yuan's General HospitalKaohsiung Veterans General Hospital.; Sin-Lau HospitalUnknownAcute Myocardial Infarction, of Inferolateral Wall | Acute Myocardial Infarction, of Inferoposterior WallTaiwan
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Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Acute Coronary Syndrome | Acute Myocardial Infarction | Metabolic DisturbanceGreece
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Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
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Sheba Medical CenterCompletedNon ST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
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Medstar Health Research InstituteWithdrawnST-elevation Myocardial Infarction | Acute Myocardial InfarctionUnited States
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Hennepin Healthcare Research InstituteSiemens HealthineersActive, not recruitingAcute Coronary Syndrome | Acute Myocardial InfarctionUnited States
Clinical Trials on AMI Choice Decision Aid
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Aristotle University Of ThessalonikiMayo Clinic; European Foundation for the Study of DiabetesCompleted
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Wake Forest University Health SciencesUniversity of North Carolina, Chapel Hill; American Cancer Society, Inc.CompletedColorectal Cancer | Health LiteracyUnited States
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Mayo ClinicPatient-Centered Outcomes Research Institute; University of California, Davis; Indiana University and other collaboratorsCompletedChest Pain | Acute Coronary SyndromeUnited States
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Mayo ClinicCompletedCardiovascular Disease | Diabetes Mellitus | Dyslipidemia | HypercholesterolemiaUnited States
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Mayo ClinicCompletedOsteoporosis | Postmenopausal Osteoporosis | Postmenopausal Bone Loss | Bone Loss, Age RelatedUnited States
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Icahn School of Medicine at Mount SinaiMayo ClinicCompleted
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Mayo ClinicAmerican Diabetes AssociationCompleted
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Boston CollegeCompleted
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Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
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Henry Ford Health SystemCompleted