NCT02637440

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
560

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2015

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

3.9 years

First QC Date

December 17, 2015

Last Update Submit

December 21, 2015

Conditions

Multivessel Coronary Artery DiseaseSTEMIFFR Guided PCI

Outcome Measures

Primary Outcomes (1)

  • Composite of cardiovascular death, myocardial infarction and / or revascularization

    1 year

Secondary Outcomes (6)

  • Cardiovascular morality

    1 year

  • Myocardial infarction

    1 year

  • Revascularization

    1 year

  • stroke

    1 year

  • Heart failure

    1 year

  • +1 more secondary outcomes

Other Outcomes (1)

  • Bleeding

    1 year

Study Arms (3)

Conservative

NO INTERVENTION

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 guided

ACTIVE COMPARATOR

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

Procedure: FFR guided PCI

angiogram guided

ACTIVE COMPARATOR

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

Procedure: Angio guided PCI

Interventions

FFR guided PCIPROCEDURE

Patients undergo Fractional Flow measurement (FFR) followed by PCI, if the FFR is less than 0.8

FFR guided
Angio guided PCIPROCEDURE

Patients receive PCI without FFR measurement

angiogram guided

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Galway University Hospital

Galway, Galway, Ireland

Location

University Hospital Limerick

Limerick, Limerick, 000, Ireland

Location

Related Publications (3)

  • 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.

    PMID: 25766941BACKGROUND

  • 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.

    PMID: 26498666RESULT

  • 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.

    PMID: 26347918RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Thomas J Kiernan, MD

    University Hospital of Limerick

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas J Kiernan, MD

CONTACT

+35361482684tom_kiernan@hotmail.com

Abdullah S Abdullah, MBBS, MRCPI, MSc

CONTACT

++35361482684abdalasayid@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 22, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

IE(2)