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The Use Of FFR Guided PCI Versus Complete Revascularization and Treatment Of Infarct Related Artery Only In Patients With STEMI (FAIO)

Primary Purpose

Multivessel Coronary Artery Disease, STEMI, FFR Guided PCI

Status
Unknown status
Phase
Phase 3
Locations
Ireland
Study Type
Interventional
Intervention
FFR guided PCI
Angio guided PCI
Sponsored by
University of Limerick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multivessel Coronary Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with STEMI and multi-vessel disease on initial angiogram.
  2. Above 18 years of age
  3. Able to give consent

Exclusion Criteria:

  1. Patients with indication for CABG
  2. Left main stem lesion of >50%
  3. Cardiogenic shock
  4. Intractable angina during hospital admission
  5. Patients with limited life expectancy
  6. Patients with severe chronic kidney disease
  7. Patients with contraindication to dual antiplatelet therapy
  8. Patients with very complex lesions that deemed not favourable for PCI
  9. Pregnancy or childbearing age

Sites / Locations

  • Galway University Hospital
  • University Hospital Limerick

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Conservative

FFR guided

angiogram guided

Arm Description

After the index primary PCI. The control group will receive best medical therapy and regular follow up and only PCI for recurrent angina with evidence of inducible ischaemia.

FFR group will undergo FFR at 4 weeks of the index primary PCI as OPD. If FFR is less than 0.8, then PCI will be performed

The group will undergo PCI for all significant lesions more than 50

Outcomes

Primary Outcome Measures

Composite of cardiovascular death, myocardial infarction and / or revascularization

Secondary Outcome Measures

Cardiovascular morality
Myocardial infarction
Revascularization
Revascularization procedure because of symptoms and evidence of ischaemia
stroke
Heart failure
documented episode of presentation with symptoms consistent with heart failure and evidence from echocardiogram or laboratory test consistent with the diagnosis of heart failure
Costs
total procedural costs, hospital stay costs, medications costs.

Full Information

First Posted
December 17, 2015
Last Updated
December 21, 2015
Sponsor
University of Limerick
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1. Study Identification

Unique Protocol Identification Number
NCT02637440
Brief Title
The Use Of FFR Guided PCI Versus Complete Revascularization and Treatment Of Infarct Related Artery Only In Patients With STEMI
Acronym
FAIO
Official Title
Multi Centre Open Label Randomised Controlled Parallel-group Three Arm Trial To Compare The Use Of Fractional Flow Reserve (FFR) Guided and Angiographically Guided Revascularization To The Treatment Of Infarct Related Artery Only In Patients With STEMI And Multivessel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Limerick

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In patients with ST elevation myocardial infarction (STEMI) the treatment goal is revascularization of the occluded artery with the use of primary percutaneous coronary intervention (PCI). There is a large subset of patients with STEMI who also have significant disease in arteries other than the site of occlusion, and away from the culprit artery. It is estimated that up to 50% have disease of more than 50% in the non-culprit arteries. The evidence on how to treat those patients with multi vessel disease is conflicting. Earlier large-scale studies and registries have suggested early and complete revascularization is of no benefit or even harmful. More recent studies have showed the opposite of that. The CVLPRIT study showed that early complete revascularization or preventive PCI reduced primary endpoint of a composite of all cause mortality, myocardial infarction and need for repeat revascularization. The benefit was mainly due to reduced repeat revascularization in the more intensive intervention group. The PRAMI study showed very similar results as well. The use of Fractional flow Reserve (FFR) in deciding complete revascularization has also showed conflicting results so far. A previous trial showed that FFR guided intervention post STEMI increased MACE. This was conflicted with more recent study, which showed FFR guided complete revascularization improved outcome when compared with more conservative treatment of ischaemia driven intervention. In this study, the investigators are going to assess the issue of staged revascularization guided by FFR or by angiogram, compared to the standard treatment of ischaemia driven revascularization
Detailed Description
To compare the clinical outcomes measured by composite of mortality, myocardial infarction and repeat revascularization by using FFR guided and angiographically guided revascularization to the standard strategy of ischaemia driven revascularization. Participants will be allocated to three arms, first conservative group of ischaemia guided PCI, second FFR guided PCI and third angiogram guided PCI where patients where patients with more than 50% lesion will undergo revascularization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multivessel Coronary Artery Disease, STEMI, FFR Guided PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conservative
Arm Type
No Intervention
Arm Description
After the index primary PCI. The control group will receive best medical therapy and regular follow up and only PCI for recurrent angina with evidence of inducible ischaemia.
Arm Title
FFR guided
Arm Type
Active Comparator
Arm Description
FFR group will undergo FFR at 4 weeks of the index primary PCI as OPD. If FFR is less than 0.8, then PCI will be performed
Arm Title
angiogram guided
Arm Type
Active Comparator
Arm Description
The group will undergo PCI for all significant lesions more than 50
Intervention Type
Procedure
Intervention Name(s)
FFR guided PCI
Intervention Description
Patients undergo Fractional Flow measurement (FFR) followed by PCI, if the FFR is less than 0.8
Intervention Type
Procedure
Intervention Name(s)
Angio guided PCI
Intervention Description
Patients receive PCI without FFR measurement
Primary Outcome Measure Information:
Title
Composite of cardiovascular death, myocardial infarction and / or revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cardiovascular morality
Time Frame
1 year
Title
Myocardial infarction
Time Frame
1 year
Title
Revascularization
Description
Revascularization procedure because of symptoms and evidence of ischaemia
Time Frame
1 year
Title
stroke
Time Frame
1 year
Title
Heart failure
Description
documented episode of presentation with symptoms consistent with heart failure and evidence from echocardiogram or laboratory test consistent with the diagnosis of heart failure
Time Frame
1 year
Title
Costs
Description
total procedural costs, hospital stay costs, medications costs.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Bleeding
Description
any major bleeding (TIMI 3)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with STEMI and multi-vessel disease on initial angiogram. Above 18 years of age Able to give consent Exclusion Criteria: Patients with indication for CABG Left main stem lesion of >50% Cardiogenic shock Intractable angina during hospital admission Patients with limited life expectancy Patients with severe chronic kidney disease Patients with contraindication to dual antiplatelet therapy Patients with very complex lesions that deemed not favourable for PCI Pregnancy or childbearing age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas J Kiernan, MD
Phone
+35361482684
Email
tom_kiernan@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah S Abdullah, MBBS, MRCPI, MSc
Phone
++35361482684
Email
abdalasayid@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Kiernan, MD
Organizational Affiliation
University Hospital of Limerick
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galway University Hospital
City
Galway
Country
Ireland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Hynes, MRCPI
Facility Name
University Hospital Limerick
City
Limerick
ZIP/Postal Code
000
Country
Ireland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah S Abdullah, MBBS, MSc

12. IPD Sharing Statement

Citations:
PubMed Identifier
25766941
Citation
Gershlick AH, Khan JN, Kelly DJ, Greenwood JP, Sasikaran T, Curzen N, Blackman DJ, Dalby M, Fairbrother KL, Banya W, Wang D, Flather M, Hetherington SL, Kelion AD, Talwar S, Gunning M, Hall R, Swanton H, McCann GP. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015 Mar 17;65(10):963-72. doi: 10.1016/j.jacc.2014.12.038.
Results Reference
background
PubMed Identifier
26498666
Citation
Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Ting HH, O'Gara PT, Kushner FG, Ascheim DD, Brindis RG, Casey DE Jr, Chung MK, de Lemos JA, Diercks DB, Fang JC, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol. 2016 Mar 15;67(10):1235-1250. doi: 10.1016/j.jacc.2015.10.005. Epub 2015 Oct 21. No abstract available. Erratum In: J Am Coll Cardiol. 2016 Mar 29;67(12):1506.
Results Reference
result
PubMed Identifier
26347918
Citation
Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Clemmensen P, De Backer O, Ravkilde J, Tilsted HH, Villadsen AB, Aaroe J, Jensen SE, Raungaard B, Kober L; DANAMI-3-PRIMULTI Investigators. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015 Aug 15;386(9994):665-71. doi: 10.1016/s0140-6736(15)60648-1.
Results Reference
result

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The Use Of FFR Guided PCI Versus Complete Revascularization and Treatment Of Infarct Related Artery Only In Patients With STEMI

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