Gait Speed for Predicting Cardiovascular Events After Myo... | NCT01484158

Studies
Gait Speed for Predicting Cardiovascular Events After Myocardial Infarction

NCT01484158

Sponsor

Yokohama City University Medical Center

Status

Completed

Last Update Posted

Jan 22, 2015Estimated

Enrollment

450Actual

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2001

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Nov 30, 2011

First Submission Date that Met QC Criteria

Dec 1, 2011

First Posted Date

Dec 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2015

Last Update Posted Date

Jan 22, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yasushi Matsuzawa, Primary Investigator, Yokohama City University Medical CenterPrincipal Investigator

Lead Sponsor

Yokohama City University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

450Actual

Label	Type	Description	Intervention Names
Myocardial Infarction		Patients with myocardial infarction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular Events	cardiovascular death, non-fatal myocardial infarction and non-fatal stroke	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

History of prior myocardial infarction
Cerebrovascular disease with residual hemiplegia
Severe peripheral arterial disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with acute myocardial infarction.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23500222	Derived	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.

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases