An early invasive strategy is superior to a selectively invasive strategy for patients who have acute coronary syndromes without ST-segment elevation and with an elevated cardiac troponin T level.
ID
Bron
Verkorte titel
Aandoening
Acute coronary syndromes
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary end point is <br>
1. A composite of death; <br>
2. Nonfatal myocardial infarction; <br>
3. Or rehospitalization for anginal symptoms within one year after randomization.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
An early invasive strategy is superior to a selectively invasive strategy for patients who have acute coronary syndromes
without ST-segment elevation and with an elevated cardiac troponin T level.
Onderzoeksproduct en/of interventie
Against a background of optimized medical therapy patients are randomized between an early invasive strategy or a selective invasive strategy.
The early invasive strategy include angiography within 24 to 48 hours after randomization and revascularization when appropriate.
The selective invasive strategy include medical stabilization, with angiography and revascularization only in case of refractory angina or significant ischemia on the pre discharge exercise test.
Algemeen / deelnemers
Department of Cardiology, B2-137,
P.O. Box 22660
R.J. Winter, de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
r.j.dewinter@amc.uva.nl
Wetenschappers
Department of Cardiology, B2-137,
P.O. Box 22660
R.J. Winter, de
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
r.j.dewinter@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Symptoms of ischemia that were increasing or occurred at rest, with the last episode occurring no more than 24 hours before randomization;
- an elevated cardiac troponin T level (≥0.03µg per liter);
2. and either ischemic changes as assessed by electrocardiography (defined as ST-segment depression or transient ST-segment elevation exceeding 0.05 mV,
3. or T-wave inversion of ≥0.2 mV in two contiguous leads)
4. or a documented history of coronary artery disease as evidenced by previous myocardial infarction,
5. findings on previous coronary angiography, or a positive exercise test.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Age younger than 18 years or older than 80 years;
2. Myocardial infarction with ST-segment elevation in the past 48 hours;
3. An indication for primary percutaneous coronary intervention or fibrinolytic therapy,
- hemodynamic instability or overt congestive heart failure;
4. The use of oral anticoagulant drugs in the past 7 days,;
5. Fibrinolytic treatment within the past 96 hours;
6. Percutaneous coronary intervention within the past 14 days;
7. A contraindication to treatment with percutaneous coronary intervention or glycoprotein IIb/IIIa inhibitors;
8. Recent trauma or risk of bleeding;
9. Hypertension despite treatment and weight greater than 120 kg.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL401 |
| NTR-old | NTR442 |
| Ander register | : N/A |
| ISRCTN | ISRCTN82153174 |