Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD. (CompareAcute)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Maasstad Hospital
Sponsor:
Collaborators:
Abbott Vascular
St. Jude Medical
Information provided by (Responsible Party):
Maasstad Hospital
ClinicalTrials.gov Identifier:
NCT01399736
First received: July 20, 2011
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

The Compare-Acute trial is a prospective randomised trial in patients with multivessel disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The purpose of the study is to compare a FFR guided multivessel PCI taking place during the primary PCI with a primary PCI of the culprit vessel only.

Patients will be enrolled after successful revascularisation of the culprit vessel. Patients that have at least one lesion with a diameter of stenosis of more than 50% on visual estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related artery, will be randomised either to the FFR guided complete revascularisation arm or staged revascularisation by proven ischemia or persistence of symptoms of angina.

Approximately 885 patients will be entered in the study.

Study hypothesis: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines.


Condition Intervention Phase
Myocardial Infarction
Multivessel Coronary Artery Disease
Procedure: FFR-guided revascularisation strategy
Procedure: randomised to guidelines group
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease

Resource links provided by NLM:


Further study details as provided by Maasstad Hospital:

Primary Outcome Measures:
  • Composite endpoint of MACCE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups


Secondary Outcome Measures:
  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged or acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients with FFR positive lesion that received optimal medical treatment.

  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients receiving staged PCI treatment for FFR positive lesions in the non-IRA

  • Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged PCI treatment for FFR negative lesions in the non-IRA vs the subgroup of patients not receiving PCI treatment for FFR negative lesions in the non-IRA.

  • Composite endpoint of NACE [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12, 24 and 36 months (NACE i.e. Net Adverse Clinical Events)

  • Composite endpoint hospitalisation HF and UAP [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    A composite of hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months

  • All cause mortality and MI [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    All cause mortality or Myocardial infarction at 12, 24 and 36 months

  • Revascularisation [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Any revascularisation at 12, 24 and 36 months

  • Stent thrombosis [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Stent thrombosis at 12, 24 and 36 months

  • Bleeding [ Time Frame: 48 hour and 12 months ] [ Designated as safety issue: Yes ]
    Bleeding at 48 hr and 12 months

  • Treatment costs [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: No ]
    Treatment costs 12, 24 and 36 months

  • Primary endpoint at 24 and 36 [ Time Frame: 12, 24 and 36 months ] [ Designated as safety issue: Yes ]
    Primary endpoint at 24 and 36 months as well as outcomes of each component of the primary endpoint at 12, 24 and 36 months.


Estimated Enrollment: 885
Study Start Date: July 2011
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FFR-guided revascularisation strategy
In the FFR-group all flow limiting (FFR≤0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload which may lead to deterioration of cardiac and renal function of the patient. Such procedures can be performed in a second procedure which should take place within the same hospitalisation. All lesions with a FFR measurement of >0.80 will not be treated.
Procedure: FFR-guided revascularisation strategy
FFR-guided revascularisation strategy
Placebo Comparator: randomised to guidelines group
In the randomised to guidelines group the procedure will stop after the FFR measurements and the patient will be referred to his treating cardiologist who will decide whether a staged PCI of the non-IRA artery should take place. The treating cardiologist will be blinded for the FFR measurements (but not angiographic imaging) and must make a decision based on conventional non-invasive ischemia detecting tests or clinical signs and symptoms i.e. very typical angina symptoms in patients with angiographic significant stenosis).
Procedure: randomised to guidelines group
Staged revascularisation by proven ischemia or persistence of symptoms of angina

Detailed Description:

Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques.

Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2)

Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI.

Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Primary study parameters/outcome of the study: Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients between 18-85 years presenting with STEMI who will be treated with primary PCI in < 12 h after the onset of symptoms* and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.

    • Patients with symptoms for more than 12 hr but ongoing angina complaints can be randomised

Exclusion Criteria:

  1. Left main stem disease (stenosis > 50%)
  2. STEMI due to in-stent thrombosis
  3. Chronic total occlusion of a non-IRA
  4. Severe stenosis with TIMI flow ≤ II of the non-IRA artery.
  5. Non-IRA stenosis not amenable for PCI treatment (operators decision)
  6. Complicated IRA treatment, with one or more of the following;

    • Extravasation,
    • Permanent no re-flow after IRA treatment (TIMI flow 0-1),
    • Inability to implant a stent
  7. Known severe cardiac valve dysfunction that will require surgery in the follow-up period.
  8. Killip class III or IV already at presentation or at the completion of culprit lesion treatment.
  9. Life expectancy of < 2 years.
  10. Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Bivaluridin, or Everolimus and known true anaphylaxis to prior contrast media of bleeding diathesis or known coagulopathy.
  11. Gastrointestinal or genitourinary bleeding within the prior 3 months,
  12. Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
  13. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  14. Pregnancy or planning to become pregnant any time after enrolment into this study.
  15. Inability to obtain informed consent.
  16. Expected lost to follow-up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399736

Contacts
Contact: Peter Smits, MD, PHD +31102913322 smitsp@maasstadziekenhuis.nl
Contact: Ria van Vliet +31102913278 VlietM@maasstadziekenhuis.nl

Locations
Czech Republic
University Hospital BRNO Recruiting
Brno, Czech Republic
Contact: Petr Kala, MD PhD         
Principal Investigator: Petr Kala, MD PhD         
University Hospital Hradec Králové Not yet recruiting
Hradec Králové, Czech Republic
Contact: J. Štásek, MD PhD         
Principal Investigator: J. Štásek, MD PhD         
Liberic Regional Hospital Not yet recruiting
Liberic, Czech Republic
Contact: D. Horak, MD PhD         
Principal Investigator: D. Horak, MD PhD         
Germany
Herz-Zentrum Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Principal Investigator: Franz-Josef Neumann, MD         
Herzzentrum Bad Segeberger Klinik Recruiting
Bad Segeberg, Germany, 23795
Principal Investigator: Gert Richardt, MD         
Klinikum der Weser Recruiting
Bremen, Germany
Contact: Rainer Hambrecht, PhD         
Principal Investigator: Rainer Hambrecht, PhD         
Klinikum Links der Weser Recruiting
Bremen, Germany, 28277
Contact: Rainer Hambrecht, MD PHD         
Principal Investigator: Rainer Hambrecht, MD PHD         
Medizinische Klinik IV Recruiting
Ingolstadt, Germany, 85049
Contact: Karl Heinz Seidl, MD, PHD         
Principal Investigator: Karl Heinz Seidl, MD PHD         
Deutsches Herzzentrum München Withdrawn
München, Germany, 80636
Medical University Rostock Recruiting
Rostock, Germany, 18057
Principal Investigator: Christoph Nienaber, MD         
Hungary
Gottsegen György Országos Kardiológiai Intézet Recruiting
Budapest, Hungary
Contact: Zsolt Piroth, MD PhD         
Principal Investigator: Zsolt Piroth, MD PhD         
Szabolcs - Szatmár - Bereg County Hospitals and University Teaching Hospital Recruiting
Nyíregyháza, Hungary
Contact: Zsolt Kőszegi, MD PhD         
Principal Investigator: Zsolt Kőszegi, MD PhD         
Luxembourg
INCCI (Luxembourg Heart Institute) Withdrawn
Luxembourg, Luxembourg
Netherlands
Academic Medical Center Not yet recruiting
Amsterdam, Netherlands, 1105 AZ
Principal Investigator: J.P.S. Henriques, MD         
Rijnstate Hospital Not yet recruiting
Arnhem, Netherlands
Contact: Peter Danse, MD PhD         
Principal Investigator: Peter Danse, MD PhD         
Atrium MC Parkstad Recruiting
Heerlen, Netherlands
Contact: Jan Hoorntje, MD PhD         
Principal Investigator: Jan Hoorntje, MD PhD         
Maasstadhospital Recruiting
Rotterdam, Netherlands, 3079DZ
Principal Investigator: Peter Smits, MD, Phd         
Medisch Centrum Haaglanden Recruiting
The Hague, Netherlands, 2512 VA
Principal Investigator: C. Schotborgh, MD         
Norway
Oslo University Hospital Recruiting
Oslo, Norway
Principal Investigator: Ketil Linde, MD, PhD         
Poland
Miedziowe Centrum Zdrowia Lubin Recruiting
Lubin, Poland
Contact: Adrian Włodarczak, MD PhD         
Principal Investigator: Adrian Włodarczak, MD PhD         
Centralny Szpital Kliniczny MSWiA w Warszawie Recruiting
Warsaw, Poland
Contact: Robert Gil, MD PhD         
Principal Investigator: Robert Gil, MD PhD         
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ Not yet recruiting
Wroclaw, Poland
Contact: Krzysztof Reczuch, MD PhD         
Principal Investigator: Krzysztof Reczuch, MD PhD         
Singapore
Tan Tock Seng Hospital Recruiting
Singapore, Singapore, 308433
Contact: Paul Ong, MD         
Principal Investigator: Paul Ong, MD         
Khoo Teck Puat Hospital Recruiting
Singapore, Singapore, 768828
Contact: Hean Yee Ong, MD         
Principal Investigator: Hean Yee Ong, MD         
Sweden
Sahlgrenska Götheborg University Hospital Recruiting
Goteborg, Sweden, 41315
Principal Investigator: Elmir Omerovic, MD         
Sponsors and Collaborators
Maasstad Hospital
Abbott Vascular
St. Jude Medical
Investigators
Principal Investigator: Peter Smits, MD. PHD Maastadhospital / MCR
Study Chair: Elmir Omerovic, MD PhD Sahlgrenska Hospital Götheborg
Study Chair: Gert Richardt, MD PhD Herzzentrum Segeberger Kliniken
Study Chair: Franz-Josef Neumann, MD PhD Herz-Zentrum Bad Krozingen
  More Information

No publications provided

Responsible Party: Maasstad Hospital
ClinicalTrials.gov Identifier: NCT01399736     History of Changes
Other Study ID Numbers: Compare-Acute
Study First Received: July 20, 2011
Last Updated: August 14, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Germany: Ethics Commission
Sweden: Regional Ethical Review Board
Norway: Regional Ethics Commitee
Singapore: Domain Specific Review Boards
Poland: Ethics Committee
Czech Republic: Ethics Committee
Hungary: Research Ethics Medical Committee

Keywords provided by Maasstad Hospital:
PCI FFR STEMI MVD
FFR guided PCI in acute STEMI patients with MVD

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on August 28, 2014