Acute Myocardial InfarctionNCT00888537
Wiser Choices in Acute Myocardial Infarction
A study testing AMI Choice Decision Aid in people with Acute Myocardial Infarction, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- AMI Choice Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Marys Hospital, Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- AMI Choice Decision Aid, Usual Care
- Keywords
- Decision aid, Heart attack, myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMI Choice Decision AidOther
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 CareOther
Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid | Experimental | 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. Receives: Other: AMI Choice Decision Aid |
| Usual Care | Active comparator | Patients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increases adherence to cardiac medications with proven benefits
Measured: 6 months
Reduces patients' decisional conflict (increase patient decisional quality)
Measured: During hospital stay
Decreases rehospitalization rates and death
Measured: 5 weeks and 6 months
Increase patient knowledge of medication to help the heart heal
Measured: During hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilay D. Shah, Mayo Clinic
- Investigators
- Henry Ting, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888537
- Sponsor's protocol ID
- 09-000748
- Status last verified
- Mar 2016
- First submitted
- 24 Apr 2009
- Last updated
- 21 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35673524Wyatt 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.
PubMed 25179289
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wiser Choices in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00888537
- Acronym / sponsor ID
- 09-000748
- Conditions
- Acute Myocardial Infarction
- Keywords
- Decision aid, Heart attack, myocardial infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision Aid | Experimental | Other: AMI Choice Decision AidPatients 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. |
| Usual Care | Active comparator | Other: Usual CarePatients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMI Choice Decision AidThe 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. | Other | Decision Aid |
| Usual CarePatients and clinicians in this arm will discuss medications to help the heart heal after a heart attack in their usual manner. | Other | Usual Care |
Primary outcome
Increases adherence to cardiac medications with proven benefits
Time frame: 6 months
Reduces patients' decisional conflict (increase patient decisional quality)
Time frame: During hospital stay
Decreases rehospitalization rates and death
Time frame: 5 weeks and 6 months
Increase patient knowledge of medication to help the heart heal
Time frame: During hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Derived from this study: PubMed 35673524Branda 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.
- Derived from this study: PubMed 25179289Wyatt 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.
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Ting, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMI Choice Decision Aid in people with Acute Myocardial Infarction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increases adherence to cardiac medications with proven benefits (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888537, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2016.