Functional Testing Underlying Coronary Revascularisation

Stable Angina Clinical Trial

— FUTURE  

Official title:

FUnctional Testing Underlying Coronary REvascularisation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881555
• Other study ID #: 2012.725
• Secondary ID: Numéro ID RCB :
• Status: Completed
• Phase: N/A
• Start date: May 27, 2013
• Est. completion date: June 10, 2017

Study information

• Verified date: June 2018
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 941
• Est. completion date: June 10, 2017
• Est. primary completion date: June 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Multivessel Coronary Artery Disease
• Myocardial Infarction
• Myocardial Ischemia
• Non-ST Elevated Myocardial Infarction
• Patients With ST-elevated Myocardial Infarction
• Revascularization of Culprit Coronary Artery
• ST Elevation Myocardial Infarction
• Stable Angina
• Unstable Angina or Stabilized Non-ST Elevated Myocardial Infarction
• Vessel Disease

Intervention

Procedure:
• invasive coronary angiography

• Functional testing by fractional flow reserve measurement
Functional testing by fractional flow reserve measurement

Locations

Country	Name	City	State
France	HOSPICES	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	1 year.
Primary	Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .		1 year
Secondary	Major cardiovascular events in all patients, in diabetic patients, by revascularization strategy (angioplasty, coronary artery bypass graft surgery, medical optimal treatment).		1 year
Secondary	The effect of our therapeutic strategy will be assessed upon each category of cardiovascular event individually.		1 year
Secondary	Major cardiovascular events in all patients.		2 years, 3 years, 4 years and 5 years
Secondary	Stent thrombosis.		1 year
Secondary	Bleeding events.		1 year
Secondary	Patient's quality of life	We will use the European Quality of Life-5 Dimensions instrument.	1 year
Secondary	Cost-effectiveness of each therapeutic strategy	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.	1 year
Secondary	Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .		1 year