Optimal Timing of Coronary Intervention in Unstable Angina 2.

Urgent versus Early Coronary Angiography in Non-ST-Elevation Acute Coronary Syndromes: The OPTIMA2 study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26173

Enrollment

350

Registered

2013-02-16

Start date

2013-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSTE-ACS

Interventions

Diagnostic angiography: When to perform PCI: After informed consent is obtained, the patient will be randomized to urgent or early angiography. During diagnostic angiography a culprit artery should be

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 21 years; 2. Typical chest pain for angina pectoris lasting at least 10 minutes, within the last 24 hours; 3. No contra-indication to PCI; 4. And at least one of the following criteria: A. 1 mm of horizontal or downsloping ST depression; B. Dynamic ST- or T- wave changes > 1 mm in two contiguous leads; C. Elevated hs troponin (>1xULN); D. Known coronary artery disease; E. Two of following risk factors: DM, known hypertension, current smoking, family history for ischemic heart disease, hypercholesterolemia, peripheral artery disease, age over 60 years.

Exclusion criteria

Exclusion criteria: 1. Acute ST myocardial infarction; 2. Refractory angina; 3. Severe heart failure; 4. Life-threatening ventricular arrhythmias; 5. Haemodynamic instability; 6. Contraindication for the use of a P2Y12 platelet receptor inhibitor; 7. Participation in another study; 8. Use of oral anticoagulants; 9. Patient is not capable of making a rational decision whether to participate, as is judged by investigators discretion.

Design outcomes

Primary

Measure	Time frame
Size of MI during initial hospitalization as measured by the AUC of CK-MB.	—

Secondary

Measure	Time frame
1. Size of MI during initial hospitalization as measured by the AUC of CK-MB for the subpopulation of patients treated with PCI; 2. The composite endpoint of death, MI and unplanned revascularization at 30 days; 3. The composite endpoint of MI and major haemorrhage; 4. Incidence of major haemorrhage up to 30 days; 5. Incidence of minor haemorrhage up to 30 days; 6. Incidence of individual and composite endpoints at 30 days and 6 and 12 months and 5 years including recurrent NSTE-ACS; 7. Any revascularisation and/or restenosis (TVR) up to 6 months; 8. Re-hospitalisation because of coronary artery disease (CAD).	—

Measure

Time frame

1. Size of MI during initial hospitalization as measured by the AUC of CK-MB for the subpopulation of patients treated with PCI; 2. The composite endpoint of death, MI and unplanned revascularization at 30 days; 3. The composite endpoint of MI and major haemorrhage; 4. Incidence of major haemorrhage up to 30 days; 5. Incidence of minor haemorrhage up to 30 days; 6. Incidence of individual and composite endpoints at 30 days and 6 and 12 months and 5 years including recurrent NSTE-ACS; 7. Any revascularisation and/or restenosis (TVR) up to 6 months; 8. Re-hospitalisation because of coronary artery disease (CAD).

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Contacts

Public ContactF.J. Oosterwerff

Hogeweg 90-2

f.j.oosterwerff@olvg.nl+31 (0)6 19220860

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)