Functional Testing Underlying Coronary Revascularisation (FUTURE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01881555
First received: May 29, 2013
Last updated: August 8, 2014
Last verified: December 2013
  Purpose

The objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2 therapeutic strategies, one based on coronary angiography guidance and the other based on coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery disease patients.

The trial is a prospective, multicenter, French, randomized clinical trial including men and women ≥ 18 years presenting with significant multivessel disease defined by coronary angiography as coronary narrowing > 50% diameter stenosis in at least 2 major epicardic vessels. The patients who give their informed consent will be randomly assigned to a therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this multivessel evaluation (angiography or FFR), the investigator will choose the best therapeutic strategy to his discretion (medical optimal treatment, coronary stenting, coronary artery bypass graft surgery). The aim of revascularization procedures will be to obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be treated.

The primary end point of the trial is a composite of major cardiovascular events including death from any cause, myocardial infarction, any hospitalization for coronary revascularization performed in addition to initial treatment and stroke at 1 year of follow-up.

Secondary end points will include adverse events, individual major cardiovascular events, stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.


Condition Intervention
Multivessel Coronary Artery Disease
Vessel Disease
Stable Angina
Unstable Angina or Stabilized Non-ST Elevated Myocardial Infarction
Patients With ST-elevated Myocardial Infarction
Revascularization of Culprit Coronary Artery
Procedure: invasive coronary angiography
Procedure: Functional testing by fractional flow reserve measurement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: FUnctional Testing Underlying Coronary REvascularisation.

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • composite endpoint that includes the rate of major cardiovascular events defined as a composite of death from any cause, myocardial infarction, any hospitalization leading to additional coronary revascularization, stroke. [ Time Frame: 1 year. ] [ Designated as safety issue: No ]
    The effect of therapeutic strategy will be assessed by the reduction of the incidence of major cardiovascular events in the group "angiography with FFR testing" in comparison to the group "angiography alone". Patients will be prospectively and clinically followed during the duration of the study and all major cardiovascular events will be documented and reported in the electronic case report form.

  • Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography . [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major cardiovascular events in all patients, in diabetic patients, by revascularization strategy (angioplasty, coronary artery bypass graft surgery, medical optimal treatment). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The effect of our therapeutic strategy will be assessed upon each category of cardiovascular event individually. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Major cardiovascular events in all patients. [ Time Frame: 2 years, 3 years, 4 years and 5 years ] [ Designated as safety issue: No ]
  • Stent thrombosis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Bleeding events. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Patient's quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    We will use the European Quality of Life-5 Dimensions instrument.

  • Cost-effectiveness of each therapeutic strategy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    NACost-effectiveness of each therapeutic strategy will be assessed by the evaluation of medical costs linked to the pathology (hospitalizations, consultations, and external medical costs (biology, radiology, medications) and compared in the 2 groups during the first 12 months of follow up.

  • Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography . [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1728
Study Start Date: May 2013
Estimated Study Completion Date: November 2020
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
FRACTIONAL FLOW RESERVE

Patients will have FFR measured in each diseased vessel identified by the coronary angiographic evaluation. Intra-coronary adenosine (at least 100 micrograms performed 2 times) OR intravenous adenosine (at a dose of 140µg/kg/min during at least 4 minutes) will be administered prior to FFR assessment.

Revascularization strategy will be based upon FFR findings and revascularization either by coronary stenting or CABG will only be performed on target lesions with FFR≤0.8.

Procedure: invasive coronary angiography
ANGIOGRAPHY
Patients undergo an angiography. Based on angiographic evaluation, the physicians define the revascularization strategy.
Procedure: Functional testing by fractional flow reserve measurement
Functional testing by fractional flow reserve measurement

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18
  • referred to the cardiologist for one of the following medical condition :

    • ST segment elevation myocardial infarction evolving for more than 7 days after revascularization of culprit coronary artery or
    • no ST elevation acute coronary syndrome with or without troponin (T or I) elevation and medically stabilized for at least 12 hours or
    • stable angina (CCS I, II or III) or
    • chest pain diagnosis with suspicion of CAD or with ischemia certificated by non invasive tests.
    • patients with at least 2 vessel disease (≥50% stenosis on angiography) including the left anterior descending coronary artery or with single vessel disease on left main coronary artery
  • Patient willing and able to provide informed, written consent
  • Patient not under legal protection
  • Patient benefiting from the French Health Insurance

Exclusion Criteria:

  • Pregnancy, childbearing, absence of effective contraception
  • Previous coronary bypass surgery
  • Planned associated valvular surgery
  • Life expectancy < 2 years
  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: NCT01881555

Contacts
Contact: Gilles RIOUFOL, PHD 4 72 35 75 29 ext +33 gilles.rioufol@chu-lyon.fr
Contact: Bernadette VAZ 4 27 85 53 26 bernadette.vaz@chu-lyon.fr

Locations
France
HOSPICES Recruiting
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01881555     History of Changes
Other Study ID Numbers: 2012.725
Study First Received: May 29, 2013
Last Updated: August 8, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Hospices Civils de Lyon:
fractional flow reserve
multivessel coronary artery disease
angiography

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Angina, Unstable
Angina, Stable
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 16, 2014