Acute Balloon Angioplasty vs. Traditional Early Invasive Treatment of Non-ST-Elevation Myocardial Infarction (DaNSTEMI2)

This study has been terminated.
(Due to insufficient patient inclusion the study has been stopped prematurely.)
Sponsor:
Collaborator:
Falck Danmark
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00493584
First received: June 27, 2007
Last updated: May 19, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention
Myocardial Infarction
Procedure: Primary Percutaneous Coronary Intervention
Procedure: Coronary angiography / Percutaneous coronary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Acute Angioplasty (Primary PCI) Versus Traditional Early Invasive Treatment of Patients Presenting With NSTEMI (The Second Danish Non-ST-Elevation MI Trial - DaNSTEMI-2)

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Final infarct size in the two study groups determined by MR [ Time Frame: On the 7th day after admission ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Scintigraphic Area-At-Risk and Final-Infarct-Size in patients in group A(immediate angioplasty) and group B(early invasive strategy) respectively. [ Time Frame: At the time of coronary angiography and after 30 days ] [ Designated as safety issue: No ]
  • Proportion of rerouted patients who are treated with primary PCI. [ Time Frame: At index admission ] [ Designated as safety issue: No ]
  • Proportion of patients randomized to immediate angioplasty actually undergoing primary PCI within 120 minutes from first contact to health services. [ Time Frame: At index admission ] [ Designated as safety issue: No ]
  • Number of readmissions in the two groups due to acute heart failure or reinfarction [ Time Frame: 30 days and one year ] [ Designated as safety issue: No ]
  • Total number of days admitted at hospital in relation to the index infarction in the two groups [ Time Frame: At index admission ] [ Designated as safety issue: No ]
  • Total number of days on "sick-leave" in the two groups [ Time Frame: In relation to the index admission ] [ Designated as safety issue: No ]
  • Evaluation of AAR/FIS obtained by MRI on the 7th day after admission compared to AAR and FIS obtained by myocardial perfusion imaging (scintigraphy). [ Time Frame: At the time of coronary angiography, on the 7th day after admission and after 30 days respectively. ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: March 2008
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Primary PCI in patients with acute Non-STEMI
Procedure: 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.
Active Comparator: 2
Standard medical treatment and coronary angiography after 3 days in patients with Non-STEMI.
Procedure: 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.

Detailed Description:

Primary PCI versus Traditional Early Invasive Treatment of Patients presenting with NSTEMI

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.

  Eligibility

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

Inclusion Criteria:

  1. 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).
  2. Age above 18 years.
  3. Tentative diagnosis made pre-hospitally.

Exclusion Criteria:

  1. Severe mental or psychiatric disease (eg. psychosis, dementia, bipolar disorder or depression) as well as other conditions making it impossible to obtain informed consent.
  2. Prior CABG (Coronary artery bypass graft) operation.
  3. Patients with ST-depression presumed to be caused by tachycardia or cardiac hypertrophy.
  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: NCT00493584

Locations
Denmark
Department of Cardiovascular research, Aarhus University Hospital, Skejby
DK-8200 Aarhus N, Denmark
Sponsors and Collaborators
University of Aarhus
Falck Danmark
Investigators
Principal Investigator: Jacob T Sorensen, MD Department of Cardiovascular research, Aarhus University Hospital, Skejby
Study Director: Hans E Bøtker, MD, DMSc Department of Cardiovascular research, Aarhus University Hospital, Skejby
Study Chair: 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
  More Information

Publications:
Cannon CP, Battler A, Brindis RG, Cox JL, Ellis SG, Every NR, Flaherty JT, Harrington RA, Krumholz HM, Simoons ML, Van De Werf FJ, Weintraub WS, Mitchell KR, Morrisson SL, Brindis RG, Anderson HV, Cannom DS, Chitwood WR, Cigarroa JE, Collins-Nakai RL, Ellis SG, Gibbons RJ, Grover FL, Heidenreich PA, Khandheria BK, Knoebel SB, Krumholz HL, Malenka DJ, Mark DB, Mckay CR, Passamani ER, Radford MJ, Riner RN, Schwartz JB, Shaw RE, Shemin RJ, Van Fossen DB, Verrier ED, Watkins MW, Phoubandith DR, Furnelli T. American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol. 2001 Dec;38(7):2114-30. No abstract available.

Responsible Party: Aarhus University Hospital, Skejby, Department of Cardiovascular research
ClinicalTrials.gov Identifier: NCT00493584     History of Changes
Other Study ID Numbers: Thorsted 1
Study First Received: June 27, 2007
Last Updated: May 19, 2009
Health Authority: Denmark: National Board of Health

Keywords provided by University of Aarhus:
Myocardial Infarction
Myocardial Ischemia
Myocardial Revascularization
Telemedicine
Percutaneous Transluminal Coronary Angioplasty

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014