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Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI) (LIPSIA STEMI)

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

fibrinolysis

Primary PCI

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring infarction, facilitated PCI, primary PCI, infarct size, fibrinolysis, ST-elevation myocardial infarction (STEMI)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Leipzig - Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prehospital facilitated PCI

Primary PCI

Arm Description

Outcomes

Primary Outcome Measures

Infarct size and microvascular obstruction assessed by MRI

Secondary Outcome Measures

Clinical endpoints (bleeding, death, Re-MI, stroke)

ST-segment resolution

Full Information

NCT ID

NCT00359918

First Posted

August 1, 2006

Last Updated

June 21, 2018

Sponsor

Holger Thiele

1. Study Identification

Unique Protocol Identification Number

NCT00359918

Brief Title

Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)

Acronym

LIPSIA 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

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

August 2006 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Holger Thiele

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

infarction, facilitated PCI, primary PCI, infarct size, fibrinolysis, ST-elevation myocardial infarction (STEMI)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

162 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prehospital facilitated PCI

Arm Type

Experimental

Arm Title

Primary PCI

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

fibrinolysis

Other Intervention Name(s)

Primary PCI

Intervention Description

Primary PCI

Intervention Type

Procedure

Intervention Name(s)

Primary PCI

Intervention Description

Primary PCI

Primary Outcome Measure Information:

Title

Infarct size and microvascular obstruction assessed by MRI

Time Frame

1-6 days

Secondary Outcome Measure Information:

Title

Clinical endpoints (bleeding, death, Re-MI, stroke)

Time Frame

30 days

Title

ST-segment resolution

Time Frame

90 min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Holger Thiele, MD, PhD

Organizational Affiliation

Heart Center Leipzig - University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Leipzig - Heart Center

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

24962156

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.

Results Reference

derived

PubMed Identifier

21700245

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.

Results Reference

derived

Learn more about this trial

Randomized Multicenter Trial of Prehospital Initiated Facilitated Percutaneous Coronary Intervention (PCI) Versus Primary PCI in ST-segment-Elevation MI (STEMI)

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