Acute Balloon Angioplasty vs. Traditional Early Invasive Treatment of Non-ST-Elevation Myocardial Infarction

NCT00493584 | Terminated DMC

• 1 other identifier: Thorsted 1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is: 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.

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; Myocardial Ischemia; Myocardial Revascularization; Telemedicine; Percutaneous Transluminal Coronary Angioplasty

Outcome Measures

Primary Outcomes (1)

• Final infarct size in the two study groups determined by MR

  On the 7th day after admission

Secondary Outcomes (7)

• Scintigraphic Area-At-Risk and Final-Infarct-Size in patients in group A(immediate angioplasty) and group B(early invasive strategy) respectively.

  At the time of coronary angiography and after 30 days

• Proportion of rerouted patients who are treated with primary PCI.

  At index admission

• Proportion of patients randomized to immediate angioplasty actually undergoing primary PCI within 120 minutes from first contact to health services.

  At index admission

• Number of readmissions in the two groups due to acute heart failure or reinfarction

  30 days and one year

• Total number of days admitted at hospital in relation to the index infarction in the two groups

  At index admission

Study Arms (2)

1

EXPERIMENTAL

Primary PCI in patients with acute Non-STEMI

Procedure: Primary Percutaneous Coronary Intervention

2

ACTIVE COMPARATOR

Standard medical treatment and coronary angiography after 3 days in patients with Non-STEMI.

Procedure: Coronary angiography / Percutaneous coronary intervention

Interventions

Primary Percutaneous Coronary Intervention PROCEDURE

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.

1

Coronary angiography / Percutaneous coronary intervention PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with symptoms and signs of NSTEMI and significant ECG changes (Either ≥4mm cumulated ST-segment depression (horizontal or descending), or ≥2mm ST-segment depression (horizontal or descending) in two associated leads)and/or patients with positive biomarkers for myocardial infarction (troponin T) measured in the ambulance (prehospital measurement of biomarkers).
• Age above 18 years.
• Tentative diagnosis made pre-hospitally.

You may not qualify if:

• Severe mental or psychiatric disease (eg. psychosis, dementia, bipolar disorder or depression) as well as other conditions making it impossible to obtain informed consent.
• Prior CABG (Coronary artery bypass graft) operation.
• Patients with ST-depression presumed to be caused by tachycardia or cardiac hypertrophy.

Sponsors & Collaborators

• University of Aarhus: lead
• Falck Danmark: collaborator

Study Sites (1)

Department of Cardiovascular research, Aarhus University Hospital, Skejby

Dk-8200 Aarhus N, Denmark

Location

Related Publications (24)

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MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jacob T Sorensen, MD

  Department of Cardiovascular research, Aarhus University Hospital, Skejby

  PRINCIPAL INVESTIGATOR

• Hans E Bøtker, MD, DMSc

  Department of Cardiovascular research, Aarhus University Hospital, Skejby

  STUDY DIRECTOR

• Kristian A Thygesen, MD, DMSc

  Department of Cardiovascular research, Aarhus University Hospital, Aarhus Hospital

  STUDY CHAIR

• Christian J Terkelsen, MD, PhD

  Department of Cardiovascular research, Aarhus University Hospital, Skejby

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2007
• First Posted: June 28, 2007
• Study Start: March 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 20, 2009

Record last verified: 2009-05

Locations

DK (1)