Incidence of Occluded Culprit Arteries and Impact of Coronary Collaterals on Outcome in Patients With NSTEMI

NSTEMI Clinical Trial

Official title:

Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159366
• Other study ID #: NCT00402675
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2010
• Last updated: July 9, 2010
• Start date: July 2006
• Est. completion date: January 2010

Study information

• Verified date: July 2010
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary collaterals may have beneficial effects in patients with OCA.

Description:

We examined consecutive NSTEMI patients within 48 h of symptom onset. All patients underwent early invasive angiography plus optimal medical therapy. We compared baseline characteristics, procedural findings including analysis of TIMI-flow and collaterals using the Rentrop-classification, 30-day and 6-months major adverse cardiovascular events (MACE) in patients with and without totally OCA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• age between 18 and 90 years,

• onset of angina pectoris at rest <24 h or crescendo angina in recent weeks with symptoms under minimal exertion or at rest lasting <24 h,

• elevated troponin T =0.03 µg/L and

• written informed consent.

Exclusion Criteria:

• persistent angina,

• ST-segment elevation myocardial infarction (STEMI),

• hemodynamic instability including cardiogenic shock,

• oral anticoagulation therapy,

• contraindications for glycoprotein IIb/IIIa inhibitors,

• other disease with life expectancy <6 months,

• known coagulopathy,

• pregnancy,

• other suspected causes of troponin elevation as myocarditis, secondary to hypertensive crisis, or after cardiac decompensation,

• no ability to consent, and

• participation in another study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSTEMI

Intervention

Procedure:
• percutaneous coronary intervention
early timing

Locations

Country	Name	City	State
Germany	University of Leipzig	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion	6 months	No
Secondary	CK and CK-MB	Venous blood samples were taken at admission (baseline), and every 6 h subsequently for a period of 48 h.	48 hours	No