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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. (FIT)

Primary Purpose

Myocardial Infarction, Ischemia, Heart Failure

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Coronary angioplasty all lesions
Sponsored by
Azienda Ospedaliera San Camillo Forlanini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring cardiovascular diseases, heart disease, hemorrhage, coronary angioplasty, drug eluting stents

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Azienda Ospedaliera San Camillo Forlanini

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

multivessel revascularization

Arm Description

Complete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure

Outcomes

Primary Outcome Measures

death at 30 days
stent thrombosis
target vessel failure
re-acute myocardial infarction

Secondary Outcome Measures

bleeding
timi frame count
vascular site access complications

Full Information

First Posted
July 6, 2010
Last Updated
July 12, 2010
Sponsor
Azienda Ospedaliera San Camillo Forlanini
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1. Study Identification

Unique Protocol Identification Number
NCT01160900
Brief Title
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.
Acronym
FIT
Official Title
Phase III Study, Multivessel Percutaneous Treatment During Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Ospedaliera San Camillo Forlanini

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Ischemia, Heart Failure, Necrosis, Stents
Keywords
cardiovascular diseases, heart disease, hemorrhage, coronary angioplasty, drug eluting stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
multivessel revascularization
Arm Type
Experimental
Arm Description
Complete Revascularization : the Infarcted related artery was opened followed by dilatation of other significantly narrowed arteries during the same procedure
Intervention Type
Procedure
Intervention Name(s)
Coronary angioplasty all lesions
Other Intervention Name(s)
drug eluting stent, prasugrel, bivalirudin
Intervention Description
treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin
Primary Outcome Measure Information:
Title
death at 30 days
Time Frame
1 month
Title
stent thrombosis
Time Frame
1 year
Title
target vessel failure
Time Frame
1 year
Title
re-acute myocardial infarction
Time Frame
1 month
Secondary Outcome Measure Information:
Title
bleeding
Time Frame
1 month
Title
timi frame count
Time Frame
1 day
Title
vascular site access complications
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Roma
ZIP/Postal Code
00151
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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.

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