Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-01 @ 12:18 AM
Study NCT ID:
NCT01638806
Status:
TERMINATED
Last Update Posted:
2019-04-04
First Post:
2012-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction
Sponsor:
Aarhus University Hospital Skejby
Organization:
Study Overview
Official Title:
Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction (NON-ST-Elevation Myocardial Infarction=NONSTEMI Trial)
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow recuritment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NONSTEMI
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
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: