Acute Balloon Angioplasty vs. Traditional Early Invasive Treatment of Non-ST-Elevation Myocardial Infarction
NCT ID: NCT00493584
Last Updated: 2009-05-20
Study Results
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Basic Information
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TERMINATED
NA
14 participants
INTERVENTIONAL
2008-03-31
2011-03-31
Brief Summary
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A) To determine whether patients with a certain type of heart attack (NSTEMI) can be reliably diagnosed in an ambulance using telemedicine. This is mandatory if NSTEMI patients in the future are to be treated with acute balloon angioplasty (primary PCI).
B) To evaluate whether primary PCI compared with the current regimen of initial medical stabilization and sub-acute PCI results in reduction of infarct-size in NSTEMI-patients.
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Detailed Description
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Patients with NSTEMI are currently admitted for initial evaluation and stabilization at local hospitals. An intensive antithrombotic treatment is initiated and after 3 - 7 days of "cooling-off" the patients are referred to an invasive centre for coronary angiography and possibly PCI or CABG - this is known as the early invasive approach. Some of these patients represent a high-risk sub-group with occluded or sub-occluded coronary arteries who might benefit from very early revascularization.
Study Aims
1. To investigate if it is technically feasible to diagnose patients with NSTEMI in the pre-hospital setting and reroute them to an invasive heart centre for primary PCI in a timely manner.
2. To estimate area at risk (AAR = the part of cardiac muscle tissue at risk of infarction) and final infarct size (FIS) in patients referred for primary PCI and patients undergoing the traditional "early invasive" treatment, respectively.
3. To investigate whether Primary PCI in patients with NSTEMI results in a shorter duration of the primary admission, fewer rehospitalizations with reinfarction and acute heart failure and a briefer overall "sick leave" within a year from the index admission.
Methods
In this study 300 consecutive patients with symptoms, clinical signs and ECG changes (≥4mm cumulated or ≥ 2mm ST-segment depression (horizontal or descending) in two associated leads) suggesting significant NSTEMI are randomized for one of two strategies, either (A) usual early invasive treatment (coronary angiography and possibly PCI after 3 days) or (B) direct referral (rerouting) to primary PCI at an invasive heart centre (Skejby).
All patients undergo myocardial perfusion imaging at admission for PCI and again after 30 days to estimate AAR, FIS and possible myocardial salvage.
All patients undergo cardiac MRI on the 7th day after admission for determination of AAR and FIS.
The study is a randomized controlled study; it has been approved by the local ethics committee.
Primary outcome measures are specified above
If the study confirms that it is possible to diagnose and re-route NSTEMI patients for primary PCI with an acceptable diagnostic accuracy, then a larger scale mortality study will be planned. Furthermore, the present study will provide valuable information regarding AAR and FIS in NSTEMI-patients which may be of value for planning larger-scale, scintigraphic studies and for the possible future use of a single MRI scan to determine AAR and FIS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1
Primary PCI in patients with acute Non-STEMI
Primary Percutaneous Coronary Intervention
Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.
2
Standard medical treatment and coronary angiography after 3 days in patients with Non-STEMI.
Coronary angiography / Percutaneous coronary intervention
Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.
Interventions
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Primary Percutaneous Coronary Intervention
Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.
Coronary angiography / Percutaneous coronary intervention
Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance.
Eligibility Criteria
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Inclusion Criteria
2. Age above 18 years.
3. Tentative diagnosis made pre-hospitally.
Exclusion Criteria
2. Prior CABG (Coronary artery bypass graft) operation.
3. Patients with ST-depression presumed to be caused by tachycardia or cardiac hypertrophy.
18 Years
ALL
No
Sponsors
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Falck Danmark
UNKNOWN
University of Aarhus
OTHER
Responsible Party
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Department of Cardiovascular research
Principal Investigators
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Jacob T Sorensen, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiovascular research, Aarhus University Hospital, Skejby
Hans E Bøtker, MD, DMSc
Role: STUDY_DIRECTOR
Department of Cardiovascular research, Aarhus University Hospital, Skejby
Kristian A Thygesen, MD, DMSc
Role: STUDY_CHAIR
Department of Cardiovascular research, Aarhus University Hospital, Aarhus Hospital
Christian J Terkelsen, MD, PhD
Role: STUDY_CHAIR
Department of Cardiovascular research, Aarhus University Hospital, Skejby
Locations
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Department of Cardiovascular research, Aarhus University Hospital, Skejby
Dk-8200 Aarhus N, , Denmark
Countries
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References
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Other Identifiers
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Thorsted 1
Identifier Type: -
Identifier Source: org_study_id
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