AzTrials
AzTrials

Cardiovascular DiseasesPhase 3NCT00000493

Multicenter Investigation of Limitation of Infarct Size (MILIS)

A Phase 3 study testing propranolol and hyaluronidase in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 74 years
What is being tested?
propranolol and hyaluronidase
How many people
Not given
Where
No sites listed yet
Study dates
Sep 1977to Dec 1985
Phase
Phase 3
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 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Men and women, under age 75. Documented myocardial infarction which could be treated within 18 hours of onset of ischemic symptoms.

About this study

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.

Read the 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 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.

The study completion date listed in this record was obtained from the "End Date" entered in the Query View Report (QVR).

Being tested
propranolol, hyaluronidase
Medical subject headings
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 1999 (estimated)
  2. Study startSep 1977
  3. Study completionDec 1985

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000493
Sponsor's protocol ID
12
Status last verified
Dec 1985
First submitted
27 Oct 1999
Last updated
12 Jul 2016
Results posted
No

Publications

  • Rude RE, Poole WK, Muller JE, Turi Z, Rutherford J, Parker C, Roberts R, Raabe DS Jr, Gold HK, Stone PH, et al. Electrocardiographic and clinical criteria for recognition of acute myocardial infarction based on analysis of 3,697 patients. Am J Cardiol. 1983 Nov 1;52(8):936-42. doi: 10.1016/0002-9149(83)90508-8.

    PubMed 6356862

  • Hackel DB, Reimer KA, Ideker RE, Mikat EM, Hartwell TD, Parker CB, Braunwald EB, Buja M, Gold HK, Jaffe AS, et al. Comparison of enzymatic and anatomic estimates of myocardial infarct size in man. Circulation. 1984 Nov;70(5):824-35. doi: 10.1161/01.cir.70.5.824.

    PubMed 6488496

  • Mukharji J, Rude RE, Poole WK, Gustafson N, Thomas LJ Jr, Strauss HW, Jaffe AS, Muller JE, Roberts R, Raabe DS Jr, et al. Risk factors for sudden death after acute myocardial infarction: two-year follow-up. Am J Cardiol. 1984 Jul 1;54(1):31-6. doi: 10.1016/0002-9149(84)90299-6.

    PubMed 6741836

  • Roberts R, Croft C, Gold HK, Hartwell TD, Jaffe AS, Muller JE, Mullin SM, Parker C, Passamani ER, Poole WK, et al. Effect of propranolol on myocardial-infarct size in a randomized blinded multicenter trial. N Engl J Med. 1984 Jul 26;311(4):218-25. doi: 10.1056/NEJM198407263110403.

    PubMed 6377070

  • Croft CH, Rude RE, Lewis SE, Parkey RW, Poole WK, Parker C, Fox N, Roberts R, Strauss HW, Thomas LJ, et al. Comparison of left ventricular function and infarct size in patients with and without persistently positive technetium-99m pyrophosphate myocardial scintigrams after myocardial infarction: analysis of 357 patients. Am J Cardiol. 1984 Feb 1;53(4):421-8. doi: 10.1016/0002-9149(84)90006-7.

    PubMed 6320623

  • Muller JE (Ed.), Braunwald E, Mock MB, et al (Assoc. Eds.): National Heart, Lung, and Blood Institute Multicenter Investigation of the Limitation of Infarct Size (MILIS). Design and Methods of the Clinical Trial. An Investigation of Beta-Blockade and Hyaluronidase for Treatment of Acute Myocardial Infarction. AHA Monograph 100:1-134, 1984.

  • Turi ZG, Rutherford JD, Roberts R, Muller JE, Jaffe AS, Rude RE, Parker C, Raabe DS, Stone PH, Hartwell TD, et al. Electrocardiographic, enzymatic and scintigraphic criteria of acute myocardial infarction as determined from study of 726 patients (A MILIS Study). Am J Cardiol. 1985 Jun 1;55(13 Pt 1):1463-8. doi: 10.1016/0002-9149(85)90954-3.

    PubMed 2988325

  • Muller JE, Stone PH, Turi ZG, Rutherford JD, Czeisler CA, Parker C, Poole WK, Passamani E, Roberts R, Robertson T, et al. Circadian variation in the frequency of onset of acute myocardial infarction. N Engl J Med. 1985 Nov 21;313(21):1315-22. doi: 10.1056/NEJM198511213132103.

    PubMed 2865677

  • Muller JE, Turi ZG, Stone PH, Rude RE, Raabe DS, Jaffe AS, Gold HK, Gustafson N, Poole WK, Passamani E, Smith TW, Braunwald E; MILIS Study Group. Digoxin therapy and mortality after myocardial infarction. Experience in the MILIS Study. N Engl J Med. 1986 Jan 30;314(5):265-71. doi: 10.1056/NEJM198601303140501.

    PubMed 3510391

  • Wheelan K, Mukharji J, Rude RE, Poole WK, Gustafson N, Thomas LJ Jr, Strauss HW, Jaffe AS, Muller JE, Roberts R, et al. Sudden death and its relation to QT-interval prolongation after acute myocardial infarction: two-year follow-up. Am J Cardiol. 1986 Apr 1;57(10):745-50. doi: 10.1016/0002-9149(86)90606-5.

    PubMed 2870632

  • Rude RE, Buja LM, Willerson JT. Propranolol in acute myocardial infarction: the MILIS experience. Am J Cardiol. 1986 Apr 25;57(12):38F-42F. doi: 10.1016/0002-9149(86)90887-8.

    PubMed 2871744

  • Hyaluronidase therapy for acute myocardial infarction: results of a randomized, blinded, multicenter trial. MILIS Study Group. Am J Cardiol. 1986 Jun 1;57(15):1236-43. doi: 10.1016/0002-9149(86)90195-5.

    PubMed 2872794

  • Turi ZG, Stone PH, Muller JE, Parker C, Rude RE, Raabe DE, Jaffe AS, Hartwell TD, Robertson TL, Braunwald E. Implications for acute intervention related to time of hospital arrival in acute myocardial infarction. Am J Cardiol. 1986 Aug 1;58(3):203-9. doi: 10.1016/0002-9149(86)90047-0.

    PubMed 3739907

  • Croft CH, Rude RE, Gustafson N, Stone PH, Poole WK, Roberts R, Strauss HW, Raabe DS Jr, Thomas LJ, Jaffe AS, et al. Abrupt withdrawal of beta-blockade therapy in patients with myocardial infarction: effects on infarct size, left ventricular function, and hospital course. Circulation. 1986 Jun;73(6):1281-90. doi: 10.1161/01.cir.73.6.1281.

    PubMed 3009050

  • Lamas GA, Muller JE, Turi ZG, Stone PH, Rutherford JD, Jaffe AS, Raabe DS, Rude RE, Mark DB, Califf RM, et al. A simplified method to predict occurrence of complete heart block during acute myocardial infarction. Am J Cardiol. 1986 Jun 1;57(15):1213-9. doi: 10.1016/0002-9149(86)90191-8.

    PubMed 3717016

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing propranolol and hyaluronidase in people with Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 12 Jul 2016. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000493, which also lists 36 linked publications.

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 12 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in