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.

NCT04566497 | Recruiting DMC

• 1 other identifier: P170908J
• Study Type: interventional
• Target: 2,664
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stress testing; Myocardial ischemia; Coronary artery disease; coronary revascularization

Outcome Measures

Primary Outcomes (4)

• demonstrate the non-inferiority of a strategy of clinical follow-up

  The primary outcomes measured at longest follow-up (minimum 24 months) the number of All-cause death in each arm

  minimum 24 months to 48 months

• demonstrate the non-inferiority of a strategy of clinical follow-up

  The primary outcomes measured at longest follow-up (minimum 24 months) is the number of Myocardial infarction in each arm

  minimum 24 months to 48 months

• demonstrate the non-inferiority of a strategy of clinical follow-up

  The primary outcomes measured at longest follow-up (minimum 24 months) is the number of Stroke in each arm hospitalization.

  minimum 24 months to 48 months

• demonstrate the non-inferiority of a strategy of clinical follow-up

  The primary outcomes measured at longest follow-up (minimum 24 months) is the number of any cardiovascular event leading to unplanned hospitalization in each arm

  minimum 24 months to 48 months

Secondary Outcomes (5)

• compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

  minimum 24 months to 48 months

• compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

  minimum 24 months to 48 months

• compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

  minimum 24 months to 48 months

• compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

  minimum 24 months to 48 months

• compare the clinical follow-up strategy to a systematic screening of myocardial ischemia

  minimum 24 months to 48 months

Study Arms (2)

Experimental

EXPERIMENTAL

no systematic stress testing during follow-up

Other: No stress testing

Active Comparator

ACTIVE COMPARATOR

systematic annual stress testing during follow-up

Procedure: stress testing

Interventions

No stress testing OTHER

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

Also known as: Arm1

Experimental

stress testing PROCEDURE

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

Also known as: Arm 2

Active Comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prior coronary revascularization (PCI or CABG) at any time before randomization.
• Asymptomatic at the time of randomization (defined as a Canadian Cardiovascular Society score ≤ 1, stable on the current medical treatment).
• Patient affiliated to Social Security
• Informed, written consent from the patient

You may not qualify if:

• Age \< 18years
• Any acute coronary syndrome in the previous 3 months
• 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.
• Any severe valvular disease
• Prior heart transplantation
• Class III or IV symptomatic heart failure (NYHA classification).
• 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
• Malignancies and other comorbid conditions with a life expectancy \< 2 years
• Pregnancy or nursing women
• Women of childbearing age without effective birth control or intention to become pregnant during the course of the trial
• Simultaneous enrollment in an interventional clinical trial and interventional research with minimal risks and burden
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitie salpetriere

Paris, France

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Interventions

26S proteasome non-ATPase regulatory subunit 13; Exercise Test; DMAC2L protein, human

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Nadjib Hammoudi, MD PHD

  APHP(ASSISTANCE PUBLIQUE DES HOPITAUX DE PARIS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadjib Hammoudi, MD PHD

CONTACT

01 42 16 55 35; nadjib.hammoudi@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 28, 2020
• Study Start: September 30, 2021
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: June 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)