Myocardial InfarctionNCT00195169
Quality of Life After Myocardial Infarction
An observational study of Myocardial Infarction, run by Weill Medical College of Cornell University.
Trial summary
This is an observational study to determine the association between social support and functional status after a myocardial infarct Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- How many people
- 213 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Aug 2009
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Convenience sample
- Patients who have had a documented myocardial infarction by EKG and laboratory criteria will be eligible. The attending cardiologist of these patients will be approached. Once the attending cardiologist declares that a patient is clinically stable enough for participation, they will be approached, told about the study, and asked if they wish to participate.
About this study
Official title: Quality of Life After Myocardial Infarction: The Impact of Social Support
This is an observational study to determine the association between social support and functional status after a myocardial infarct
Read the detailed description
Primary objectives:
Our primary objective is to determine among patients hospitalized for a myocardial infarction, the impact of emotional support on functional outcomes at two years as measured by a valid measure of functional health, the SF-36.
Secondary Objectives:
Our secondary objectives are:
- To determine the types of social support which are perceived as being most helpful to patients.
- To determine whether women and minority patients have unique views on the types of support that are helpful.
- To determine among patients admitted for myocardial infarction, the impact of social support on length of stay and hospital readmissions.
Hypothesis:
Our hypotheses are as follows:
- Patients who are hospitalized for a myocardial infarction and who have high emotional support will have better long-term functional status compared to those patients who have low support.
- Patients with high emotional support will be more likely to adhere to protocols such as taking their medications, keeping appointment, and enrolling in cardiac rehabilitation.
- Patients with high emotional support will have lengths of hospitalization which are shorter than their estimated geometric mean as compared to patients who have low support.
- The types of social support which are perceived as most helpful in disease management will be influenced by gender and ethnicity.
Long-term Objectives:
The long-term objective is to determine the mechanisms by which social support impacts on functional health and to utilize this data to develop future interventions that can be targeted toward a culturally and ethically diverse cohort of patients with coronary artery disease. Overall, the goal is to use this data to prevent functional disability and improve quality of life among patients with coronary artery disease.
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Social support
- Medical subject headings
- Myocardial Infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2001
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Investigators
- Carla Boutin-Foster, MD, Principal investigator, Joan and Sanford I. Weill Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00195169
- Sponsor's protocol ID
- 042677
- Status last verified
- Aug 2010
- First submitted
- 15 Sep 2005
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Myocardial Infarction: The Impact of Social Support
- ClinicalTrials.gov ID
- NCT00195169
- Acronym / sponsor ID
- 042677
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Social support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jul 2001
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 19 Sep 2005 (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.
This is an observational study to determine the association between social support and functional status after a myocardial infarct
Detailed description
Primary objectives:
Our primary objective is to determine among patients hospitalized for a myocardial infarction, the impact of emotional support on functional outcomes at two years as measured by a valid measure of functional health, the SF-36.
Secondary Objectives:
Our secondary objectives are:
- To determine the types of social support which are perceived as being most helpful to patients.
- To determine whether women and minority patients have unique views on the types of support that are helpful.
- To determine among patients admitted for myocardial infarction, the impact of social support on length of stay and hospital readmissions.
Hypothesis:
Our hypotheses are as follows:
- Patients who are hospitalized for a myocardial infarction and who have high emotional support will have better long-term functional status compared to those patients who have low support.
- Patients with high emotional support will be more likely to adhere to protocols such as taking their medications, keeping appointment, and enrolling in cardiac rehabilitation.
- Patients with high emotional support will have lengths of hospitalization which are shorter than their estimated geometric mean as compared to patients who have low support.
- The types of social support which are perceived as most helpful in disease management will be influenced by gender and ethnicity.
Long-term Objectives:
The long-term objective is to determine the mechanisms by which social support impacts on functional health and to utilize this data to develop future interventions that can be targeted toward a culturally and ethically diverse cohort of patients with coronary artery disease. Overall, the goal is to use this data to prevent functional disability and improve quality of life among patients with coronary artery disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Convenience sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 12 Aug 2010.
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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.
Carla Boutin-Foster, MD principal investigator
Joan and Sanford I. Weill Medical College
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Weill Medical College of Cornell University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 12 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 12 Aug 2010.