Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours

This study has been completed.
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by:
Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT00260416
First received: November 30, 2005
Last updated: May 21, 2008
Last verified: May 2008
  Purpose

Background: Acute balloon angioplasty is beneficial in patients with acute myocardial infarction. However, presently this treatment is not offered to patients with symptom duration above 12 hours.

Hypothesis: Acute balloon angioplasty for myocardial infarction is beneficial despite symptom duration above 12 hours.

Methods: In 60 patients with myocardial infarction and symptom duration above 12 hours, the proportion of non-perfused myocardium before acute angioplasty and 1 month after angioplasty is compared to evaluate if myocardial tissue can be saved by acute angioplasty despite long symptom duration.


Condition Intervention Phase
Acute Myocardial Infarction
Procedure: Primary angioplasty with stent and abciximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).

Secondary Outcome Measures:
  • Infarct size by myocardial scintigraphy at 1 month and 6 months after primary angioplasty.
  • Death at 1 month and 6 months.
  • Reinfarction at 1 month and 6 months.
  • Ejection fraction at 1 day, 1 month and 6 months.
  • Left ventricular end diastolic volume at 1 day, 1 month and 6 months.
  • Brain Natriuretic Peptide levels at 1 day, 1 month and 6 months.

Estimated Enrollment: 60
Study Start Date: May 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Methods: On arrival at our angioplasty laboratory, patients are informed about the study. If they accept to participate, we infuse 600 MBq of Sestamibi i.v. This binds in a first passage fashion without later redistribution to perfused myocardium. Non-perfused myocardium does not bind sestamibi. Primary angioplasty with stent and abciximab is then performed followed by myocardial scintigraphy to illustrate the non-perfused myocardial area that was at risk of infarction before the coronary artery was opened. Echocardiography is also performed. At 1 month, myocardial scintigraphy is repeated to evaluate infarct size. The difference between the myocardial area at risk of infarction before angioplasty and the myocardial infarct size 1 month later is defined as "salvage". Scintigraphy is repeated at 6 month and echocardiography is also repeated at 1 month and 6 months. The primary endpoint is "salvage". Accordingly, the aim is to demonstrate that salvage can be achieved with primary angioplasty for acute myocardial infarction despite symptom duration above 12 hours. Clinical endpoints are death and reinfarction. The results are compared with results in 200 patients with symptom duration below 12 hours. These patients are treated and examined according to the exact same protocol. By this comparison, it can be evaluated whether it is relevant that the current guidelines recommend acute balloon angioplasty only to patients with less than 12 hours of symptom duration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute myocardial infarction with ST-segment elevation;
  • Symptom duration 12 hours to 72 hours.

Exclusion Criteria:

  • Age below 18 years;
  • Bleeding disorders or anaemia or low levels of thrombocytes;
  • Thrombolysis used during the present admission;
  • Expected survival less than 1 year due to other diseases;
  • Previous acute myocardial infarction or coronary by-pass surgery;
  • Major operation within last 30 days;
  • Heamorrhaghic stroke within last 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260416

Locations
Denmark
Departments of Cardiology and Nuclear Medicine at Skejby Hospital
Aarhus, Denmark, DK-8200 N
Sponsors and Collaborators
Aarhus University Hospital Skejby
Danish Heart Foundation
Investigators
Study Director: Steen D. Kristensen, MD Dept. of Cardiology, Skejby Hospital, AarhusUniversity Hospital, DK-8200 Aarhus N, Denmark, Europe
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00260416     History of Changes
Other Study ID Numbers: STEMI-12
Study First Received: November 30, 2005
Last Updated: May 21, 2008
Health Authority: Denmark: National Board of Health

Keywords provided by Aarhus University Hospital Skejby:
Acute myocardial infarction
Symptom duration
Primary angioplasty
Infarct size
Myocardial scintigraphy

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Abciximab
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on July 24, 2014