Myocardial InfarctionNCT01484158
Gait Speed for Predicting Cardiovascular Events After Myocardial Infarction
An observational study of Myocardial Infarction, run by Yokohama City University Medical Center.
Trial summary
There are growing evidences that gait speed is inversely associated with all causes mortality especially cardiovascular mortality among the elderly. The purpose of this study is to evaluate the predictive value of gait speed for cardiovascular events in patients after ST-segment elevation myocardial infarction (STEMI). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Dec 2012
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute myocardial infarction.
Who may be able to join
- Clinical diagnosis of ST-segment elevation acute myocardial infarction
- Must be treated within 12 hours after symptom onset
- Must be able to walk
- Must receive successful primary percutaneous coronary intervention
Who cannot join
- History of prior myocardial infarction
- Cerebrovascular disease with residual hemiplegia
- Severe peripheral arterial disease
About this study
There are growing evidences that gait speed is inversely associated with all causes mortality especially cardiovascular mortality among the elderly. The purpose of this study is to evaluate the predictive value of gait speed for cardiovascular events in patients after ST-segment elevation myocardial infarction (STEMI).
Read the detailed description
The investigators will enroll patients capable of walking with STEMI. All patients will receive successful reperfusion therapy within 12-hour from onset. Gait speed during cardiac rehabilitation is measured. Cardiovascular events were defined as a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, for an average follow-up period.
- Conditions
- Myocardial Infarction
- Keywords
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Myocardial Infarction | Patients with myocardial infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular Events
cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startOct 2001
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasushi Matsuzawa, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484158
- Sponsor's protocol ID
- Gait Speed Outcome Study
- Status last verified
- Jan 2015
- First submitted
- 30 Nov 2011
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Matsuzawa Y, Konishi M, Akiyama E, Suzuki H, Nakayama N, Kiyokuni M, Sumita S, Ebina T, Kosuge M, Hibi K, Tsukahara K, Iwahashi N, Endo M, Maejima N, Saka K, Hashiba K, Okada K, Taguri M, Morita S, Sugiyama S, Ogawa H, Sashika H, Umemura S, Kimura K. Association between gait speed as a measure of frailty and risk of cardiovascular events after myocardial infarction. J Am Coll Cardiol. 2013 May 14;61(19):1964-72. doi: 10.1016/j.jacc.2013.02.020. Epub 2013 Mar 14.
PubMed 23500222
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Speed for Predicting Cardiovascular Events After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01484158
- Acronym / sponsor ID
- Gait Speed Outcome Study
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Oct 2001
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Dec 2011 (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.
There are growing evidences that gait speed is inversely associated with all causes mortality especially cardiovascular mortality among the elderly. The purpose of this study is to evaluate the predictive value of gait speed for cardiovascular events in patients after ST-segment elevation myocardial infarction (STEMI).
Detailed description
The investigators will enroll patients capable of walking with STEMI. All patients will receive successful reperfusion therapy within 12-hour from onset. Gait speed during cardiac rehabilitation is measured. Cardiovascular events were defined as a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, for an average follow-up period.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial Infarction | – | –Patients with myocardial infarction |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute myocardial infarction.
Key inclusion criteria (4 listed)
- Clinical diagnosis of ST-segment elevation acute myocardial infarction
- Must be treated within 12 hours after symptom onset
- Must be able to walk
- Must receive successful primary percutaneous coronary intervention
Key exclusion criteria (3 listed)
- History of prior myocardial infarction
- Cerebrovascular disease with residual hemiplegia
- Severe peripheral arterial disease
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
Cardiovascular Events
Time frame: 5 years
cardiovascular death, non-fatal myocardial infarction and non-fatal stroke
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 22 Jan 2015.
- Derived from this study: PubMed 23500222Matsuzawa Y, Konishi M, Akiyama E, Suzuki H, Nakayama N, Kiyokuni M, Sumita S, Ebina T, Kosuge M, Hibi K, Tsukahara K, Iwahashi N, Endo M, Maejima N, Saka K, Hashiba K, Okada K, Taguri M, Morita S, Sugiyama S, Ogawa H, Sashika H, Umemura S, Kimura K. Association between gait speed as a measure of frailty and risk of cardiovascular events after myocardial infarction. J Am Coll Cardiol. 2013 May 14;61(19):1964-72. doi: 10.1016/j.jacc.2013.02.020. Epub 2013 Mar 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Yokohama City University Medical Center.
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 4 inclusion and 3 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 22 Jan 2015. 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.
What does the primary outcome measure?
Cardiovascular Events (time frame: 5 years). 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 NCT01484158, which also lists 1 linked publication.
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 22 Jan 2015; AzTrials last refreshed its copy on 7 Nov 2026.