Clinical trial NCT00359918: Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)
Official title: Randomized, Controlled Multicenter Trial of Prehospital Initiated Facilitated PCI Versus Primary PCI in Patients With STEMI LIPSIA-STEMI Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Keywords: infarction
facilitated PCI
primary PCI
infarct size
fibrinolysis
ST-elevation myocardial infarction (STEMI)
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2006-08-03
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prehospital initiated facilitation of primary percutaneous coronary intervention by fibrinolysis might be helpful in re-opening the infarct related artery prior to percutaneous coronary intervention.

This studies tests the hypothesis that prehospital initiated facilitated PCI is superior to primary percutaneous coronary intervention with respect to infarct size.

Detailed description: Patients with STEMI with symptoms \< 3 hours are randomized in the region of Leipzig to either prehospital full-dose fibrinolysis (+ASA, Clopidogrel and heparin) with subsequent facilitated percutaneous coronary intervention or to primary percutaneous coronary intervention (after ASA + heparin + clopidogrel).

Patients undergo cardiac magnetic resonance for assessment of infarct size early at day 1-4 after randomization.

Eligibility criteria: Inclusion Criteria:

* Angina pectoris \< 3 hours
* ST-elevation myocardial infarction

Exclusion Criteria:

* Active bleeding
* Active gastric ulcus
* Previous stroke
* Uncontrolled hypertension (\> 200 mmHg)
* Cerebral surgery \< 8 weeks
* Major surgery \< 4 weeks
* Malignancy
* Treatment with coumarines
* Pregnancy

Primary outcomes:
measure: Infarct size and microvascular obstruction assessed by MRI
timeFrame: 1-6 days
Secondary outcomes:
measure: Clinical endpoints (bleeding, death, Re-MI, stroke)
timeFrame: 30 days
measure: ST-segment resolution
timeFrame: 90 min
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Waha S, Eitel I, Desch S, Fuernau G, Lurz P, Stiermaier T, Blazek S, Schuler G, Thiele H. Prognosis after ST-elevation myocardial infarction: a study on cardiac magnetic resonance imaging versus clinical routine. Trials. 2014 Jun 25;15:249. doi: 10.1186/1745-6215-15-249.
citation: Thiele H, Eitel I, Meinberg C, Desch S, Leuschner A, Pfeiffer D, Hartmann A, Lotze U, Strauss W, Schuler G; LIPSIA-STEMI Trial Group. Randomized comparison of pre-hospital-initiated facilitated percutaneous coronary intervention versus primary percutaneous coronary intervention in acute myocardial infarction very early after symptom onset: the LIPSIA-STEMI trial (Leipzig immediate prehospital facilitated angioplasty in ST-segment myocardial infarction). JACC Cardiovasc Interv. 2011 Jun;4(6):605-14. doi: 10.1016/j.jcin.2011.01.013.