Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000493
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-10-27
Brief Title:
Multicenter Investigation of Limitation of Infarct Size MILIS
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1985-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Institutes 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
The study completion date listed in this record was obtained from the End Date entered in the Query View Report QVR
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 Institutes 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
The study completion date listed in this record was obtained from the End Date entered in the Query View Report QVR
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: