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

NCT01638806 | Terminated DMC

• 1 other identifier: NONSTEMI
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myocardial Infarction

Keywords

Acute Coronary Syndrome; Myocardial infarction; Angioplasty; Prehospital emergency care; Biological markers; Troponin; Point-of-Care systems

Outcome Measures

Primary Outcomes (4)

• Mortality

  all-cause mortality

  within 1 year from randomization

• Re-infarction

  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.

  within 1 year from randomization

• Readmission with CHF

  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.

  within 1 year from randomization

• Confirmed AMI

  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.

  during index admission

Secondary Outcomes (9)

• Readmission with AP

  within 3 months, 1 year, and 5 year from randomization

• Readmission with stroke

  within 3 months, 1 year, and 5 year from randomization

• Non-scheduled re-intervention

  within 3 months, 1 year, and 5 year from randomization

• Duration of index admission

  Time from initial admission to discharge

• Sick-leave from work

  within 3 months, 1 year, and 5 year from randomization

Study Arms (2)

Group I: PPCI

EXPERIMENTAL

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

Conventional: Group II

NO INTERVENTION

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.

Interventions

Group I: Primary PCI PROCEDURE

Patients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI

Also known as: PPCI in NONSTEMI

Group I: PPCI

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (1)

Department of cardiology, Aarhus University Hospital in Skejby

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Rasmussen MB, Stengaard C, Sorensen JT, Riddervold IS, Sondergaard HM, Niemann T, Dodt KK, Frost L, Jensen T, Raungaard B, Hansen TM, Giebner M, Rasmussen CH, Botker HE, Kristensen SD, Maeng M, Christiansen EH, Terkelsen CJ. Comparison of Acute Versus Subacute Coronary Angiography in Patients With NON-ST-Elevation Myocardial Infarction (from the NONSTEMI Trial). Am J Cardiol. 2019 Sep 15;124(6):825-832. doi: 10.1016/j.amjcard.2019.06.007. Epub 2019 Jun 24.

  PMID: 31324357 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian J Terkelsen, MD,PhD

  Department of cardiology B, Aarhus University Hospital in Skejby, Denmark

  PRINCIPAL INVESTIGATOR

• Hans E Bøtker, MD,DmSc,Prof

  Department of cardiology B, Aarhus University Hospital in Skejby, Denmark

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, PhD

Study Record Dates

• First Submitted: June 28, 2012
• First Posted: July 12, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

DK (1)