Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-27 @ 2:24 PM
Study NCT ID:
NCT01484158
Status:
COMPLETED
Last Update Posted:
2015-01-22
First Post:
2011-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gait Speed for Predicting Cardiovascular Events After Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'We retain only blood sample only in this study.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-20', 'studyFirstSubmitDate': '2011-11-30', 'studyFirstSubmitQcDate': '2011-12-01', 'lastUpdatePostDateStruct': {'date': '2015-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular Events', 'timeFrame': '5 years', 'description': 'cardiovascular death, non-fatal myocardial infarction and non-fatal stroke'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myocardial Infarction'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '23500222', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with acute myocardial infarction.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of ST-segment elevation acute myocardial infarction\n* Must be treated within 12 hours after symptom onset\n* Must be able to walk\n* Must receive successful primary percutaneous coronary intervention\n\nExclusion Criteria:\n\n* History of prior myocardial infarction\n* Cerebrovascular disease with residual hemiplegia\n* Severe peripheral arterial disease'}, 'identificationModule': {'nctId': 'NCT01484158', 'briefTitle': 'Gait Speed for Predicting Cardiovascular Events After Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Yokohama City University Medical Center'}, 'officialTitle': 'Gait Speed for Predicting Cardiovascular Events After Myocardial Infarction', 'orgStudyIdInfo': {'id': 'Gait Speed Outcome Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Myocardial Infarction', 'description': 'Patients with myocardial infarction'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yokohama City University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Yasushi Matsuzawa', 'investigatorAffiliation': 'Yokohama City University Medical Center'}}}}