FAME II-10-year Follow-Up
The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design. The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence. FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published. The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization). Patients will have to sign a specific informed consent for the present 10-year follow-up. This study will be conducted for about approximately 6 months.
Conditions:
🦠 Coronary Artery Disease
πŸ—“οΈ Study Start (Actual) 25 April 2023
πŸ—“οΈ Primary Completion (Estimated) March 2024
βœ… Study Completion (Estimated) March 2024
πŸ‘₯ Enrollment (Estimated) 1212
πŸ”¬ Study Type OBSERVATIONAL
πŸ“Š Phase N/A
Locations:
πŸ“ Stanford, California, United States
πŸ“ Atlanta, Georgia, United States
πŸ“ Decatur, Georgia, United States
πŸ“ Bangor, Maine, United States
πŸ“ Aalst, Belgium
πŸ“ MontrΓ©al, Quebec, Canada
πŸ“ MontrΓ©al, Quebec, Canada
πŸ“ Brno, Moravia, Czechia
πŸ“ Praha, Czechia
πŸ“ Copenhagen, Denmark
πŸ“ Bron, Lyon, France
πŸ“ Leipzig, Saxony, Germany
πŸ“ MΓΌnchen, Germany
πŸ“ MΓΌnchen, Germany
πŸ“ Budapest, Hungary
πŸ“ Cona, Ferrara, Italy
πŸ“ Eindhoven, Noord-Brabant, Netherlands
πŸ“ Kragujevac, Ε umadija, Serbia
πŸ“ Stockholm, Sweden
πŸ“ Γ–rebro, Sweden
πŸ“ London, Camberwell, United Kingdom
πŸ“ Southampton, Hampshire, United Kingdom
πŸ“ Edinburgh, Scotland, United Kingdom
πŸ“ Belfast, Ulster, United Kingdom
πŸ“ Clydebank, United Kingdom

πŸ“‹ Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Patients with
    • 1. stable angina pectoris (Canadian Cardiovascular Society Class \[CCS\] 1, 2, 3)
    • 2. or, angina pectoris CCS class 4 subsequently stabilized medically (minimum 7 days) or,
    • 3. atypical chest pain or no chest pain but with documented silent ischemia on non-invasive testing.
    • 2. In whom at least one stenosis was present of at least 50% in one major native epicardial coronary artery with a diameter of at least 2.5 mm and supplying viable myocardium
    • 3. Eligible for PCI
    • 4. Signed written informed consent was obtained. Patients will have to sign a specific informed consent for the present 10-year follow-up.

    Exclusion Criteria:

    • 1. Patients in whom the preferred treatment is CABG
    • 2. Patients with left main coronary artery disease requiring revascularization
    • 3. Patients with a recent (less than 1 WEEK) STEMI or Non-STEMI
    • 4. Prior CABG
    • 5. Contra-indication to dual antiplatelet therapy
    • 6. LVEF \< 30%
    • 7. Severe LV hypertrophy (defined as a septal wall thickness at echocardiography of more than 13 mm)
    • 8. Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)
    • 9. Extremely tortuous or calcified coronary arteries precluding FFR measurements
    • 10. A life expectancy of less than 2 years
    • 11. Age under 21
    • 12. Pregnancy or intention to become pregnant during the course of the trial
    • 13. Refusal or inability to sign an informed consent. Mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent
    • 14. Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
    • 15. Participation or planned participation in another cardiovascular clinical trial before two year follow-up is completed
Ages Eligible for Study: 21 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

πŸ—“οΈ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 March 2023
  • First Submitted that Met QC Criteria 5 December 2023
  • First Posted 6 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 December 2023
  • Last Update Posted 6 December 2023
  • Last Verified March 2023