An interventional study of Group I: Primary PCI in Myocardial Infarction, sponsored by Aarhus University Hospital Skejby. Terminated at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-04.
Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment
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
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:
Secondary purposes of the present trial is:
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 500 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
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
Mortality
all-cause mortality
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: during index admission
Readmission with AP
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)
Time frame: within 3 months, 1 year, and 5 year from randomization
Readmission with stroke
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).
Time frame: within 3 months, 1 year, and 5 year from randomization
Non-scheduled re-intervention
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)
Time frame: within 3 months, 1 year, and 5 year from randomization
Duration of index admission
The national health registry is used to determine number of days the patietns was admitted during index hospitalization (local hospital and interventional hospital).
Time frame: Time from initial admission to discharge
Sick-leave from work
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.
Time frame: within 3 months, 1 year, and 5 year from randomization
Total cost
The total cost for each treatment strategy is calculated: EMS-transport, admission, cost for PCI / CABG.
Time frame: within 3 months, 1 year, and 5 year from randomization
Bleeding
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. In addition BARC type 4 (CABG-related) bleedings are registered.
Time frame: within 3 months, 1 year, and 5 year from randomization
Time to intervention
The time frame is equal to the health care system delay (time from EMS call to intervention)
Time frame: Time from ambulance call to PCI or CABG is performed or angiography is performed without indication for PCI or CABG
Cardiovascular mortality
Cardiovascular mortality according to the Danish Registry of Cause of Death.
Time frame: within 3 months, 1 year, and 5 year from randomization
This study is terminated, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Aarhus University Hospital Skejby