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. (FIT)

July 12, 2010 updated by: Azienda Ospedaliera San Camillo Forlanini

Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00151
        • Azienda Ospedaliera San Camillo Forlanini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: multivessel revascularization
Complete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure
Procedure: Coronary angioplasty all lesions
treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin
Other Names:
  • drug eluting stent, prasugrel, bivalirudin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
death at 30 days
Time Frame: 1 month
1 month
stent thrombosis
Time Frame: 1 year
1 year
target vessel failure
Time Frame: 1 year
1 year
re-acute myocardial infarction
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
bleeding
Time Frame: 1 month
1 month
timi frame count
Time Frame: 1 day
1 day
vascular site access complications
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera San Camillo Forlanini

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (Estimate)

July 13, 2010

Study Record Updates

Last Update Posted (Estimate)

July 13, 2010

Last Update Submitted That Met QC Criteria

July 12, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sperimental Registry n°844

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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