Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.

NCT ID: NCT04566497

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2664 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2025-09-30

Brief Summary

Due to the lack of randomized controlled trials, the best follow-up strategy of asymptomatic patients after coronary artery revascularization is controversial. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival. Moreover, stress testing per se or additional procedures which can be performed with regard of stress testing results can cause unexpected complications.

ARCACHON is a national, multicenter, randomized, open label trial, that will evaluate the non-inferiority of a clinical follow-up as compared to a systematic stress testing strategy after coronary revascularization.

Detailed Description

Coronary artery revascularization is commonly used for the management strategy of patients with coronary artery disease (CAD).

In the following years after revascularization, the current guidelines recommend evaluation with stress tests when patients are symptomatic. Due to the lack of randomized trials, the evaluation of asymptomatic patients is controversial and accordingly there is a wide variation in routine follow-up strategies in these patients. A systematic screening of silent myocardial ischemia may help prevent a major acute cardiac event. However, systematic screening strategy is costly and there is currently no evidence that repeated revascularization improve survival We hypothesized that clinical follow-up alone would be non-inferior to systematic stress testing screening strategy during follow-up of asymptomatic CAD patients with prior coronary revascularization.

The primary objective of ARCACHON trial is to demonstrate the non-inferiority of a strategy of clinical follow-up (without non-invasive stress testing) in asymptomatic patients with a history of coronary revascularization compared to a strategy of systematic screening for myocardial ischemia using non-invasive stress testing by the primary endpoint as the composite of: all-cause death, myocardial infarction, stroke or any cardiovascular event leading to unplanned hospitalization.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention; Coronary Artery Bypass Grafting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental

no systematic stress testing during follow-up

Group Type: EXPERIMENTAL

No stress testing

Intervention Type: OTHER

No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic

Active Comparator

systematic annual stress testing during follow-up

Group Type: ACTIVE_COMPARATOR

stress testing

Intervention Type: PROCEDURE

Systematic annual stress testing during the patient follow up (up to 48 months)

Interventions

No stress testing

No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic

Intervention Type: OTHER

stress testing

Systematic annual stress testing during the patient follow up (up to 48 months)

Intervention Type: PROCEDURE

Other Intervention Names

Arm1; Arm 2

Eligibility Criteria

Inclusion Criteria

1. Prior coronary revascularization (PCI or CABG) at any time before randomization.

2. Asymptomatic at the time of randomization (defined as a Canadian Cardiovascular Society score ≤ 1, stable on the current medical treatment).

3. Patient affiliated to Social Security

4. Informed, written consent from the patient

Exclusion Criteria

1. Age < 18years

2. Any acute coronary syndrome in the previous 3 months

3. Symptoms suggestive of angina pectoris at the time of randomization:

• Angina is characterized by ischemic chest pain occurring on exertion or stress relieved by rest and/or nitroglycerine.
• Angina equivalents are defined as dyspnea, fatigue, or diaphoresis on exertion evaluated by the principal investigator as abnormal and attributable to myocardial ischemia.

4. Any severe valvular disease

5. Prior heart transplantation

6. Class III or IV symptomatic heart failure (NYHA classification).

7. Persons whose occupations impact on public safety (e.g. airline pilots, lorry or bus drivers) in whom systematic stress testing could be required for medico-legal reasons

8. Malignancies and other comorbid conditions with a life expectancy < 2 years

9. Pregnancy or nursing women

10. Women of childbearing age without effective birth control or intention to become pregnant during the course of the trial

11. Simultaneous enrollment in an interventional clinical trial and interventional research with minimal risks and burden

12. Inability to sign an informed consent. Patient under legal protection (guardianship, curatorship) or 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadjib Hammoudi, MD PHD

Role: PRINCIPAL_INVESTIGATOR

APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS

Locations

Pitie salpetriere

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nadjib Hammoudi, MD PHD

Role: CONTACT

nadjib.hammoudi@aphp.fr

01 42 16 55 35 ext. +33

Other Identifiers

P170908J

Identifier Type: -

Identifier Source: org_study_id