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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00260416 |
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Date of registration:
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30/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours
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Scientific title:
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Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00260416 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Steen D. Kristensen, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dept. of Cardiology, Skejby Hospital, AarhusUniversity Hospital, DK-8200 Aarhus N, Denmark, Europe |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Myocardial Infarction
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Intervention(s)
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Procedure: Primary angioplasty with stent and abciximab
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Primary Outcome(s)
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Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).
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Secondary Outcome(s)
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Left ventricular end diastolic volume at 1 day, 1 month and 6 months.
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Infarct size by myocardial scintigraphy at 1 month and 6 months after primary angioplasty.
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Reinfarction at 1 month and 6 months.
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Ejection fraction at 1 day, 1 month and 6 months.
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Brain Natriuretic Peptide levels at 1 day, 1 month and 6 months.
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Death at 1 month and 6 months.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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