Optimal Timing of Coronary Intervention in Unstable Angina.

Recruiting

• Conditions: STE-ACS

• Registration Number: NL-OMON22720

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 600

Inclusion Criteria

1. Age > 21 years;
2. Typical chest pain for angina pectoris lasting at least 10 minutes, within last 6 hours;
3. No contra-indication to PCI;

And at least one of the following criteria:
1. 1 mm of horizontal or downsloping ST depression;
2. Dynamic ST- or T- wave changes > 1 mm in two contiguous leads;
3. Elevated troponin or CK-Mb;
4. Known coronary artery disease;
5. Two of following risk factors: DM, known hypertension, current smoking, family hx, hypercholesterolaemia, peripheral artery disease, age over 60 years.

Exclusion Criteria

1. Chest pain suspected not to be caused by CAD;
2. Acute myocardial infarction requiring reperfusion therapy;
3. Thrombolytic therapy <24 hours / indication for trombolytic therapy;
4. Recent PCI (<14 days);
5. Thrombopenia (<100*1012/mm3);
6. Severe bleeding < 6 weeks;
7. Major surgery < 6 weeks;
8. Cerebral haemorrhage in medical history;
9. High blood pressure left untreated;(diastolic > 100 mmHg, systolic > 180 mmHg);
10. Life expectancy < 1 year due to co morbidity;
11. Known intracranial malformation or -neoplasm;
12. Participation in other study possibly interfering with the endpoints;
13. Inability to follow up;
14. Culprit lesion is a restenotic lesion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite incidence of death, MI and revascularization up to 30 days post enrolment.

Secondary Outcome Measures

Name	Time	Method
1. Size of MI during initial hospitalization, quantified as peak CK-MB (mass), cumulative positive CK-Mb's;<br>2. 6 month angiographic restenosis as a composite endpoint with, “large” MI and death;<br>3. Incidence of individual and composite endpoints at 30 days and 6 and 12 months including recurrent NSTE-ACS;<br>4. Any revascularisation and/or restenosis (TVR) up to 6 months; <br>5. Re-hospitalisation because of coronary artery disease (CAD);<br>6. Incidence of major haemorrhage up to 30 days;<br>7. Hospital costs.