The Prognostic Value of Positive Stress Echocardiography and Its Relationship with Invasive Coronary Angiography: the AMPHIPOLIS Study

The stress echo-Amphipolis trial (NCT...) is a prospective, multicenter, self-controlled, open-label trial to evaluate the positive prognostic value of stress echocardiography and its relationship with ICA in patients with established or suspected coronary artery disease (CAD). The study is organized by the Working Group of Echocardiography (WGE) and it is endorsed by the Hellenic Cardiology Society (HCS), which has undertaken the structure of a common web-based platform to connect all echo labs.

Recruitment: The stress echo-Amphipolis trial will consecutively enroll adults with a positive SE based on echocardiographic findings. Then eligible patients will be asked to participate in the study and all their clinical and demographic parameters will be recorded in a web-based platform. Participants will undergo ICA within 6 weeks, and the results will be added in the platform. It will be conducted at 25 echocardiography labs in Greece and Cyprus. An open invitation has been previously sent to high-volume centers performing annually a significant number of SE (>250) to participate.

Therapy: Decision of therapy, either revascularization or conservative, will be at the discretion of the cardiologist of each patient. Post-SE pharmaceutical therapy will be prescribed in all patients according to current international guidelines.

Follow-up: Then patients will be followed up for at least 12 months to collect structured data regarding MACE: cardiovascular death, acute coronary syndromes (ACSs), revascularization interventions (re-stenosis or new cases of myocardial ischemia), developing symptoms (angina relapse or new onset). The time interval between SE and MACE will be recorded. Within follow-up period, all patients will be contacted by phone or with on-site visit for at least once. Surveillance data will be retrieved from medical records and patients will be asked for new symptoms onset of symptoms relapse. The total duration of the study is expected to be 2 years.

Committees: Besides this, the study will be monitored by 2 independent scientific groups: 1) The organizing committee (OC) consisting of the members of the core of the WGE, which will be responsible for the conduction of the study, data collection and monitoring/guiding of centers. 2) The Adjudication Committee (AC) which is comprised of cardiologists with high experience in SE coming from Greece and other countries. Moreover, written report and digital images should be available to the AC. This committee will decide in ambiguous cases of clinical endpoints achievement or will provide an expert opinion when there is a mismatch between SE and ICA findings. A 5% of cases will be randomly selected for a blind cross check from the AC.