Clinical trial NCT01638806: Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction
Official title: Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction (NON-ST-Elevation Myocardial Infarction=NONSTEMI Trial)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Infarction
Keywords: Acute Coronary Syndrome
Myocardial infarction
Angioplasty
Prehospital emergency care
Biological markers
Troponin
Point-of-Care systems
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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=250 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 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

Primary outcomes:
measure: Mortality
timeFrame: within 1 year from randomization
measure: Re-infarction
timeFrame: within 1 year from randomization
measure: Readmission with CHF
timeFrame: within 1 year from randomization
measure: Confirmed AMI
timeFrame: during index admission
Secondary outcomes:
measure: Readmission with AP
timeFrame: within 3 months, 1 year, and 5 year from randomization
measure: Readmission with stroke
timeFrame: within 3 months, 1 year, and 5 year from randomization
measure: Non-scheduled re-intervention
timeFrame: within 3 months, 1 year, and 5 year from randomization
measure: Duration of index admission
timeFrame: Time from initial admission to discharge
measure: Sick-leave from work
timeFrame: within 3 months, 1 year, and 5 year from randomization
measure: Total cost
timeFrame: within 3 months, 1 year, and 5 year from randomization
measure: Bleeding
timeFrame: within 3 months, 1 year, and 5 year from randomization
measure: Time to intervention
timeFrame: Time from ambulance call to PCI or CABG is performed or angiography is performed without indication for PCI or CABG
measure: Cardiovascular mortality
timeFrame: within 3 months, 1 year, and 5 year from randomization
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of cardiology, Aarhus University Hospital in Skejby
Study officials:
affiliation: Department of cardiology B, Aarhus University Hospital in Skejby, Denmark
name: Christian J Terkelsen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of cardiology B, Aarhus University Hospital in Skejby, Denmark
name: Hans E Bøtker, MD,DmSc,Prof
role: STUDY_DIRECTOR
affiliation: Department of cardiology B, Aarhus University Hospital in Skejby, Denmark
name: Carsten Stengaard, MD
role: STUDY_CHAIR
affiliation: Department of cardiology B, Aarhus Unversity Hospital in Skejby, Denmark
name: Jacob T Sørensen, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.