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Functional Testing Underlying Coronary Revascularisation (FUTURE)

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ClinicalTrials.gov Identifier: NCT01881555
Recruitment Status : Completed
First Posted : June 19, 2013
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 941 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: FUnctional Testing Underlying Coronary REvascularisation.
Study Start Date : May 27, 2013
Actual Primary Completion Date : June 10, 2017
Actual Study Completion Date : June 10, 2017
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    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.

  2. Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography . [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. The effect of our therapeutic strategy will be assessed upon each category of cardiovascular event individually. [ Time Frame: 1 year ]
  3. Major cardiovascular events in all patients. [ Time Frame: 2 years, 3 years, 4 years and 5 years ]
  4. Stent thrombosis. [ Time Frame: 1 year ]
  5. Bleeding events. [ Time Frame: 1 year ]
  6. Patient's quality of life [ Time Frame: 1 year ]
    We will use the European Quality of Life-5 Dimensions instrument.

  7. Cost-effectiveness of each therapeutic strategy [ Time Frame: 1 year ]
    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.

  8. Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography . [ Time Frame: 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881555


Locations
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France
HOSPICES
Lyon, France, 69002
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01881555    
Other Study ID Numbers: 2012.725
Numéro ID RCB : 2012-A01195-38 ( Other Identifier: ANSM )
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Keywords provided by Hospices Civils de Lyon:
fractional flow reserve
multivessel coronary artery disease
angiography
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Angina Pectoris
Angina, Stable
Angina, Unstable
ST Elevation Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Infarction
Ischemia
 Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations