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Trial NCT00000493

Resource URI: http://static.linkedct.org/resource/trials/NCT00000493
PropertyValue
linkedct:brief_title Multicenter Investigation of Limitation of Infarct Size (MILIS)
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/3388>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
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linkedct:condition <http://static.linkedct.org/resource/condition/8489>
linkedct:criteria Men and women, under age 75. Documented myocardial infarction which could be treated within 18 hours of onset of ischemic symptoms.
linkedct:description BACKGROUND: The study of methods for minimizing the mass of ischemic infarcted myocardium associated with a myocardial infarction was identified as a topic of research priority in the 1973 Report of the Panel Chairman for the Preparation of the National Heart, Blood Vessel, Lung, and Blood Program. In September 1976, the Institute convened a workshop involving 32 investigators active in this field, respondents to past solicitations, experts on the topic of collaborative clinical trials, members of previous review committees, and several members of the Cardiology Advisory Committee. The attendees were enthusiastic about the practicality and timeliness of a collaborative clinical trial in this field. The concept of collaborative clinical trials to protect ischemic myocardium was discussed by the Cardiology Advisory Committee in its meeting of September 22, 1976, and was recommended affirmatively and enthusiastically. This trial was part of the Institute's initiatives and was reviewed and favorably recommended by the National Heart, Lung, and Blood Advisory Council at its December 1976 meeting. The trial consisted of five clinical centers, six central laboratories, a clinical coordinating center, and a data coordinating center. DESIGN NARRATIVE: Randomized. Group A patients were randomized to propranolol therapy, hyaluronidase therapy, or control therapy; patients assigned to Group B (propranolol contraindicated) were assigned to hyaluronidase or control therapy. Single-blind for propranolol therapy, double-blind for hyaluronidase or control therapy; fixed sample. Detailed follow-up of clinical status and endpoints for a six-month period; annual health status follow-up thereafter.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 74 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 1985
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000493
rdfs:label Trial NCT00000493
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000493
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 12
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linkedct:overall_official <http://static.linkedct.org/resource/overall_official/25427>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000493>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/2519>
linkedct:reference <http://static.linkedct.org/resource/reference/37930>
linkedct:reference <http://static.linkedct.org/resource/reference/38413>
linkedct:reference <http://static.linkedct.org/resource/reference/38855>
linkedct:reference <http://static.linkedct.org/resource/reference/39455>
linkedct:reference <http://static.linkedct.org/resource/reference/39482>
linkedct:reference <http://static.linkedct.org/resource/reference/39529>
linkedct:reference <http://static.linkedct.org/resource/reference/39723>
linkedct:reference <http://static.linkedct.org/resource/reference/39729>
linkedct:reference <http://static.linkedct.org/resource/reference/39968>
linkedct:reference <http://static.linkedct.org/resource/reference/39980>
linkedct:reference <http://static.linkedct.org/resource/reference/39981>
linkedct:reference <http://static.linkedct.org/resource/reference/39983>
linkedct:reference <http://static.linkedct.org/resource/reference/39988>
linkedct:reference <http://static.linkedct.org/resource/reference/40187>
linkedct:reference <http://static.linkedct.org/resource/reference/40218>
linkedct:reference <http://static.linkedct.org/resource/reference/40278>
linkedct:reference <http://static.linkedct.org/resource/reference/40527>
linkedct:reference <http://static.linkedct.org/resource/reference/40651>
linkedct:reference <http://static.linkedct.org/resource/reference/40756>
linkedct:reference <http://static.linkedct.org/resource/reference/40803>
linkedct:reference <http://static.linkedct.org/resource/reference/40942>
linkedct:reference <http://static.linkedct.org/resource/reference/41160>
linkedct:reference <http://static.linkedct.org/resource/reference/41476>
linkedct:reference <http://static.linkedct.org/resource/reference/41510>
linkedct:reference <http://static.linkedct.org/resource/reference/41599>
linkedct:reference <http://static.linkedct.org/resource/reference/41648>
linkedct:reference <http://static.linkedct.org/resource/reference/41823>
linkedct:reference <http://static.linkedct.org/resource/reference/43226>
linkedct:reference <http://static.linkedct.org/resource/reference/43309>
linkedct:reference <http://static.linkedct.org/resource/reference/43352>
linkedct:reference <http://static.linkedct.org/resource/reference/43515>
linkedct:reference <http://static.linkedct.org/resource/reference/43853>
linkedct:reference <http://static.linkedct.org/resource/reference/43859>
linkedct:reference <http://static.linkedct.org/resource/reference/46588>
linkedct:reference <http://static.linkedct.org/resource/reference/49034>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date September 1977
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary To assess the ability of two separate therapeutic interventions, propranolol and hyaluronidase, to limit the ultimate size of an acute myocardial infarction. A secondary objective was to assess the influence of these therapies upon ventricular function and morbidity following myocardial infarction.
rdf:type linkedct:trials
linkedct:verification_date December 1985