NCT00260416

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 22, 2008

Status Verified

May 1, 2008

Enrollment Period

2.6 years

First QC Date

November 30, 2005

Last Update Submit

May 21, 2008

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionSymptom durationPrimary angioplastyInfarct sizeMyocardial scintigraphy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • 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.

  • +1 more secondary outcomes

Interventions

Primary angioplasty with stent and abciximabPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of Cardiology and Nuclear Medicine at Skejby Hospital

Aarhus, DK-8200 N, Denmark

Location

MeSH Terms

Interventions

StentsAbciximab

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and SuppliesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • Steen D. Kristensen, MD

    Dept. of Cardiology, Skejby Hospital, AarhusUniversity Hospital, DK-8200 Aarhus N, Denmark, Europe

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 1, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

May 22, 2008

Record last verified: 2008-05

Locations

DK(1)