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

NCT ID: NCT01638806

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2017-04-30

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

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I: PPCI

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

Group Type: EXPERIMENTAL

Group I: Primary PCI

Intervention Type: PROCEDURE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

PPCI in NONSTEMI

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: lead

Responsible Party

Christian Juhl Terkelsen

Associate professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian J Terkelsen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

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

Hans E Bøtker, MD,DmSc,Prof

Role: STUDY_DIRECTOR

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

Carsten Stengaard, MD

Role: STUDY_CHAIR

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

Jacob T Sørensen, MD, PhD

Role: STUDY_CHAIR

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

Locations

Department of cardiology, Aarhus University Hospital in Skejby

Aarhus, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 31324357 (View on PubMed)

Other Identifiers

NONSTEMI

Identifier Type: -

Identifier Source: org_study_id