Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction (NONSTEMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Aarhus University Hospital Skejby
Sponsor:
Information provided by (Responsible Party):
Christian Juhl Terkelsen, Skejby Hospital
ClinicalTrials.gov Identifier:
NCT01638806
First received: June 28, 2012
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

Patients with acute myocardial infarction (AMI) are categorized according to the electrocardiogram (ECG) findings into: 1) patients with ST-Elevation Myocardial Infarction (STEMI), 2) patients with Bundle Branch Block Myocardial Infarction (BBBMI), and 3) remaining patients with so-called NON-ST-Elevation Myocardial Infarction (NONSTEMI).

Patients with STEMI or BBBMI are treated with acute angioplasty (PPCI=primary percutaneous coronary intervention), and the sooner PPCI is performed the lower is the mortality. This is why prehospital diagnosis and field-triage of patients with STEMI directly to heart centers with PPCI facilities is recommended.

In patients with NONSTEMI previous trials have indicated that early angioplasty, within 72 hours of symptom onset, is associated with improved outcome when compared to late angioplasty or conservative therapy. No trials have so far been able to diagnose patients with NONSTEMI in the prehospital phase or immediately on arrival at a hospital, and triage them directly to PPCI. Implementation of point-of-care (POC) testing of biomarkers may enable prehospital or early inhospital establishment of the diagnosis NONSTEMI.

The aim of the present trial is to identify patients with NONSTEMI in the prehospital phase or immediately on arrival at the local hospital based on a) symptoms, b) POC testing and c) ECG findings and then randomize patients to I) PPCI, or II) medical therapy and angiography/angioplasty within 72 hours (todays routine).

Se below for detailed description


Condition Intervention
Myocardial Infarction
Procedure: Group I: Primary PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction (NON-ST-Elevation Myocardial Infarction=NONSTEMI Trial)

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Mortality [ Time Frame: within 1 year from randomization ] [ Designated as safety issue: Yes ]
    all-cause mortality

  • Re-infarction [ Time Frame: within 1 year from randomization ] [ Designated as safety issue: Yes ]
    Re-infarction (during index admission or readmitted) adjudicated by and endpoint committee. The endpoint committee is blinded to the initial randomization. The "Universal definition of Myocadial infarction" will be used to classify reinfarction. Biomarkers will be recorded with emphasis on the need of obtaining blood samples until a peak has been reached during index hospitaltization before reinfarction can be considered. Re-infarction will require a 20% relative rise in biomarker level.

  • Readmission with CHF [ Time Frame: within 1 year from randomization ] [ Designated as safety issue: Yes ]
    Readmission or visit in the outpatient clinic with CHF. Readmission or visit with CHF needs to be adjudicated by an endpoint committee blinded to the initial randomization.

  • Confirmed AMI [ Time Frame: during index admission ] [ Designated as safety issue: Yes ]
    An endpoint committee needs to evaluate whether each patient had AMI on the index admission. This evaluation is performed without the endpoint committee being aware whether the patient was randomized to PPCI or conventional therapy. The endpoint committee will classify whether the patient had: a) NONSTEMI, b) STEMI with symptom duration <=12 hours, c) STEMI with symptom duration >12 hours, d) BBBMI with symptom duration <=12 hours or e) BBBMI with symptom duration > 12 hours.


Secondary Outcome Measures:
  • Readmission with AP [ Time Frame: within 3 months, 1 year, and 5 year from randomization ] [ Designated as safety issue: No ]
    The national health registry is used to determine whether the patient is readmitted with AP. Time from index admission to first readmission with AP is determined. The endpoint committee adjudicate readmissions with AP blinded to original treatment strategy (Group I versus II)

  • Readmission with stroke [ Time Frame: within 3 months, 1 year, and 5 year from randomization ] [ Designated as safety issue: Yes ]
    The national health registry used to determine whether the patient is readmitted with stroke. Stroke was defined as focal loss of neurologic function caused by an ischemic or hemorrhagic event, with residual symptoms lasting at least 24 hours or leading to death. Time from index admission to first readmission with stroke is determined. The endpoint committee adjudicate readmissions with stroke blinded to original treatment strategy (Group I versus II).

  • Non-scheduled re-intervention [ Time Frame: within 3 months, 1 year, and 5 year from randomization ] [ Designated as safety issue: No ]
    The national health registry is used to determine whether the patient has non-scheduled re-intervention performed (re-intervention not scheduled at index admission). Time from index admission to first re-intervention and type of re-interverntion (PCI or CABG) is determined. The endpoint committee adjudicate re-interventions blinded to original treatment strategy (Group I versus II)

  • Duration of index admission [ Time Frame: Time from initial admission to discharge ] [ Designated as safety issue: No ]
    The national health registry is used to determine number of days the patietns was admitted during index hospitalization (local hospital and interventional hospital).

  • Sick-leave from work [ Time Frame: within 3 months, 1 year, and 5 year from randomization ] [ Designated as safety issue: No ]
    The national DREAM database is used to determined whether the patient is on sick leave from work after index hospitalization and the duration of sick leave from work.

  • Total cost [ Time Frame: within 3 months, 1 year, and 5 year from randomization ] [ Designated as safety issue: No ]
    The total cost for each treatment strategy is calculated: EMS-transport, admission, cost for PCI / CABG.

  • Bleeding [ Time Frame: within 3 months, 1 year, and 5 year from randomization ] [ Designated as safety issue: Yes ]
    The national health registry is used to determine bleeding events. The same criteria for bleeding classification is used as in the PLATO trial (see NEJM 2009 for details) to categorize: 1) Major life-threatening bleeding, 2) Other major bleeding, and 3) Minor bleeding

  • Time to intervention [ Time Frame: Time from ambulance call to PCI or CABG is performed or angiography is performed without indication for PCI or CABG ] [ Designated as safety issue: No ]
    The time frame is equal to the health care system delay (time from EMS call to intervention)

  • Cardiovascular mortality [ Time Frame: within 3 months, 1 year, and 5 year from randomization ] [ Designated as safety issue: Yes ]
    Cardiovascular mortality according to the Danish Registry of Cause of Death.


Estimated Enrollment: 4500
Study Start Date: June 2012
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I: PPCI
Patients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI
Procedure: Group I: Primary PCI
Patients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI
Other Name: PPCI in NONSTEMI
No Intervention: Conventional: Group II
Patients are treated as today: Admission to local hospital, Low-molecular-weight heparin (LMWH), Aspirin, ADP-blocker and within 72 hours transfer for angiography/angioplasty. Patients with a Grace score > 140 will be transferred for angiography/angioplasty within 24 hours. Patients with refractory angina, severe heart failure, life-threatening ventricular arrhythmias or haemodynamic instability will be transferred acutely for angiography/angioplasty according to the european guidelines.

Detailed Description:

In the present trial patients with a) typical angina pectoris (AP) combined with b1) rise in biomarkers on POC testing (prehospital/immediately inhospital) and/or b2) ST-segment depression of more than 0.2 mV in two contiguous leads or more than 0.1 mV in four contiguous leads are randomized to I) PPCI (same protocol as in STEMI patients) or II) medical therapy and angiography/angioplasty within 72 hours (todays routine practice).

The primary purposes of the present trial is threefold:

  1. To evaluate if it is possible to diagnose patients with NONSTEMI in the prehospital phase or immediately on arrival at the hospital (N=200 patients)
  2. To compare a combined endpoint of mortality, re-infarction (during index admission or readmitted), or readmission with Congestive Heart Failure (CHF) between group I (PPCI strategy) and group II (routine strategy) (N=2500 patients).
  3. To compare mortality between group I and II (N=4500 patients).

Secondary purposes of the present trial is:

  1. To evaluate whether there is difference in the primary endpoints in patients randomized within or after 12 hours of symptom onset.
  2. To evaluate whether there is difference in the primary endpoints in patients randomized in the prehospital phase and on admission to the hospital, respectively.
  3. To evaluate whether there is difference in the primary endpoints in patients with a final diagnosis of AMI, as adjudicated by a clinical event committee.
  4. To evaluate whether there is difference in the primary endpoints in patients with or without diabetes, respectively.
  5. To compare a combined endpoint of mortality, readmission with AMI, readmission with CHF, readmission with AP, revascularization (not planned on index admission).
  6. To compare a combined safety endpoint of stroke or serious bleeding between group I and II.
  7. To evaluate if there is difference in the frequency of PCI and CABG in group I versus II.
  8. To compare total admission time between group I and II.
  9. To compare total cost between group I and II.
  10. To compare total duration where the patient is on sick leave between group I and II
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Angina
  • Elevated biomarkers (Point-of-care testing) either prehospital or immediately on admission
  • ST-segment depression of 0.2mV or more in two contiguous leads or 0.1 mV or more in four contiguous leads.
  • Patient can be randomized either in the prehospital phase or within 30 minutes of admission to a hospital

Exclusion Criteria:

  • Tachycardia > 120
  • Age < 18 or > 80 years
  • Indication for PPCI already fulfilled
  • Dementia
  • Patient cannot understand the study information
  • Presumed "troponisme"
  • Left ventricular hypertrophy
  • Known dialysis
  • Previous CABG
  • Pregnancy
  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: NCT01638806

Contacts
Contact: Christian J Terkelsen, MD,PhD 0045 24288751 christian_juhl_terkelsen@hotmail.com
Contact: Hans E Bøtker, MD,DmSc,Prof

Locations
Denmark
Department of cardiology, Aarhus University Hospital in Skejby Recruiting
Aarhus, Denmark, 8200
Principal Investigator: Christian J Terkelsen, MD,PhD         
Sponsors and Collaborators
Aarhus University Hospital Skejby
Investigators
Principal Investigator: Christian J Terkelsen, MD,PhD Department of cardiology B, Aarhus University Hospital in Skejby, Denmark
Study Director: Hans E Bøtker, MD,DmSc,Prof Department of cardiology B, Aarhus University Hospital in Skejby, Denmark
Study Chair: Carsten Stengaard, MD Department of cardiology B, Aarhus University Hospital in Skejby, Denmark
Study Chair: Jacob T Sørensen, MD, PhD Department of cardiology B, Aarhus Unversity Hospital in Skejby, Denmark
  More Information

No publications provided

Responsible Party: Christian Juhl Terkelsen, Associate professor, MD, PhD, Skejby Hospital
ClinicalTrials.gov Identifier: NCT01638806     History of Changes
Other Study ID Numbers: NONSTEMI
Study First Received: June 28, 2012
Last Updated: July 9, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital Skejby:
Acute Coronary Syndrome
Myocardial infarction
Angioplasty
Prehospital emergency care
Biological markers
Troponin
Point-of-Care systems

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 September 15, 2014