FIT (Fast Infarction Treatment): Complete Revascularization During Primary Percutaneous Coronary Intervention (PCI) Can be Achieved Safely With an Improved Clinical Outcome During the Indexed Hospitalization.

Phase 3

• Conditions: Myocardial Infarction; Ischemia; Heart Failure; Necrosis; Stents
• Interventions: Procedure: Coronary angioplasty all lesions

• Registration Number: NCT01160900
• Lead Sponsor: Azienda Ospedaliera San Camillo Forlanini

Brief Summary

Few reports described outcomes of complete compared with infarct related artery (IRA) only revascularization in patients with ST elevation myocardial infarction (STEMI) and multivessel coronary disease (CAD).

The purpose of this study is to determine outcome (death, myocardial infarction, target vessel failure) of 180 consecutive patients with STEMI and multivessel CAD undergoing primary angioplasty.

Before the first angioplasty patients are randomized to 2 different strategies: 1) culprit vessel angioplasty only, 2) staged revascularization.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-12
• Last Update Submitted: 2010-07-12
• Study First Posted: 2010-07-13
• Last Update Posted: 2010-07-13
• Primary Completion: 2012-01
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• myocardial acute infarction
• prolonged chest pain (>20 minute) started less <12 hours before arrive in hospital
• ST segment elevation of >1mm in >2 contiguous leads
• new left bundle branch block
• diameter of the coronary suitable of angioplasty >2mm
• the patients agrees to the study protocol and provides a written consensus
• two or more coronary suitable for angioplasty

Exclusion Criteria

• refused written consensus
• hypersensitivity or contraindication to any of the following medications: heparin bivalirudin aspirin prasugrel stainless steel
• history of bleeding
• cardiogenic shock (PA < 90mmHg)
• chronic total occlusion in the second lesion
• TIMI Flow < II in the culprit lesion
• recent pregnancy
• history of intra-cerebral major hemorrhagic stroke
• an elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first six months post enrollment life expectancy <1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multivessel revascularization	Coronary angioplasty all lesions	Complete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure

Primary Outcome Measures

Name	Time	Method
death at 30 days	1 month
stent thrombosis	1 year
target vessel failure	1 year
re-acute myocardial infarction	1 month

Secondary Outcome Measures

Name	Time	Method
bleeding	1 month
timi frame count	1 day
vascular site access complications	1 month

Trial Locations

Locations (1)

Azienda Ospedaliera San Camillo Forlanini; 🇮🇹 Roma, Italy