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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.

A

Azienda Ospedaliera San Camillo Forlanini

Status and phase

Unknown
Phase 3

Conditions

Ischemia
Stents
Myocardial Infarction
Heart Failure
Necrosis

Treatments

Procedure: Coronary angioplasty all lesions

Study type

Interventional

Funder types

Other

Identifiers

NCT01160900
Sperimental Registry n°844

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

180 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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