FAME II-10-year Follow-Up

Coronary Artery Disease Clinical Trial

— FAME2-10yFU  

Official title:

Fractional Flow Reserve-guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients With Stable Coronary Artery Disease - FAME II, a 10-year Follow-up Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159231
• Other study ID #: CRI-086
• Status: Recruiting
• Start date: April 25, 2023
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: CoreAalst BV
• Contact: Sofie Pardaens, PhD
• Phone: 0032 53 72 42 30
• Email: sofiepardaens[@]coreaalst.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1212
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Belgium	Cardiovascular Center Aalst	Aalst
Canada	CHUM (Centre hospitalier de l'Université de Montréal)	Montréal	Quebec
Canada	Hôpital du Sacré-Cœur-de-Montréal	Montréal	Quebec
Czechia	Masaryk University - Dept. of Internal Cardiology Medicine	Brno	Moravia
Czechia	Nemocnice Na Homolce	Praha
Denmark	Rigshospitalet	Copenhagen
France	Hopital Cardiovasculaire et Pneumologique Louis Pradel	Bron	Lyon
Germany	Universität Leipzig Herzzentrum	Leipzig	Saxony
Germany	München Klinikum Innenstadt	München
Germany	Städtische Krankenhaus München-Bogenhausen	München
Hungary	Gottsegen Hungarian Institute of Cardiology	Budapest
Italy	Azienda Ospedaliera Universitaria S. Anna (Ferrara)	Cona	Ferrara
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-Brabant
Serbia	Clinical Hospital Center Kragujevac	Kragujevac	Šumadija
Sweden	Universitestssjukhuset i Örebro	Örebro
Sweden	Sodersjukhuset	Stockholm
United Kingdom	Royal Victoria Hospital	Belfast	Ulster
United Kingdom	Golden Jubilee National Hospital	Clydebank
United Kingdom	Edinburgh Heart Centre	Edinburgh	Scotland
United Kingdom	King's College Hospital	London	Camberwell
United Kingdom	Southampton University Hospital - Wessex Cardiac Unit	Southampton	Hampshire
United States	Emory University Hospital	Atlanta	Georgia
United States	Northern Light Eastern Maine Medical Center	Bangor	Maine
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
CoreAalst BV	Abbott Medical Devices

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Netherlands,  Serbia,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of major adverse cardiac events after 10 years of follow-up	10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).	10 years
Secondary	Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).	Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).	10 years
Secondary	Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).	Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).	10 years
Secondary	Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study).	Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study).	10 years