The Positive Prognostic Value of Stress Echocardiography - AMPHIPOLIS STUDY

NCT06839755 | Recruiting

• 1 other identifier: 20240901
• Study Type: observational
• Target: 390
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, multicenter, observational study of patients with recent stress echocardiography positive for myocardial ischemia. Up to now 25 echocardiography labs form Greece and Cyprus have declared their intention to participate. The investigators will enroll 390 patients with a positive stress echo, who will undergo invasive coronary angiogram and then will be followed up for at least 6 months. The objectives are the following:

1. 1.To assess the prognostic value of positive stress echo by monitoring for cardiovascular death and major adverse cardiovascular events (MACE) during the follow-up.
2. 2.To investigate the relationship of stress echo findings with invasive coronary angiography anatomical findings.
3. 3.The association of cardiovascular risk profile of participants with stress echo and coronary angiography findings.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Keywords

stress echocardiography; myocardial ischemia; prognosis; coronary artery disease

Outcome Measures

Primary Outcomes (2)

• cardiovascular death

  The number of patients died during follow-up period due to cardiovascular reasons (e.g. myocardial infarction, stroke)

  12 months

• Major cardiovascular events

  Number of patients presented with any of the following during the follow-up: acute coronary syndromes, new revascularization, angina recurrence or new myocardial ischemia diagnosis, arteries restenosis in interventional coronary angiography

  12 months

Secondary Outcomes (1)

• anatomical findings in coronary angiography

  12 months

Study Arms (1)

Patients with stress echocardiography positive for ischemia

patients with unknown and known CAD will undergo stress echocardiography for screening or monitoring purposes respectively. Patients with findings indicating myocardial ischemia will be considered eligible

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with known or unknown coronary artery disease, regardless of symptoms undergoing stress echocardiography.

You may qualify if:

• Patients with recent stress echocardiography positive for any extent of myocardial ischemia

You may not qualify if:

• HFrEF requiring viability study.
• Any symptomatic valvular disease causing symptoms.
• Established or suspected cardiomyopathy.
• Concomitant chronic diseases reducing life expectancy (active cancer, severe liver impairment, auto-immune diseases etc).
• Recent acute coronary syndrome the last week.

Sponsors & Collaborators

• Hellenic Society of Cardiology: lead
• University of Cyprus: collaborator

Study Sites (1)

Hellenic Society of Cardiology

Athens, Attica, Greece

RECRUITING

Related Publications (4)

• Picano E, Pierard L, Peteiro J, Djordjevic-Dikic A, Sade LE, Cortigiani L, Van De Heyning CM, Celutkiene J, Gaibazzi N, Ciampi Q, Senior R, Neskovic AN, Henein M. The clinical use of stress echocardiography in chronic coronary syndromes and beyond coronary artery disease: a clinical consensus statement from the European Association of Cardiovascular Imaging of the ESC. Eur Heart J Cardiovasc Imaging. 2024 Jan 29;25(2):e65-e90. doi: 10.1093/ehjci/jead250.

  PMID: 37798126 BACKGROUND

• Woodward W, Dockerill C, McCourt A, Upton R, O'Driscoll J, Balkhausen K, Chandrasekaran B, Firoozan S, Kardos A, Wong K, Woodward G, Sarwar R, Sabharwal N, Benedetto E, Spagou N, Sharma R, Augustine D, Tsiachristas A, Senior R, Leeson P; EVAREST Investigators; EVAREST Investigators; Boardman H, d'Arcy J, Abraheem A, Banypersad S, Boos C, Bulugahapitiya S, Butts J, Coles D, Easaw J, Hamdan H, Jamil-Copley S, Kanaganayagam G, Mwambingu T, Pantazis A, Papachristidis A, Rajani R, Rasheed MA, Razvi NA, Rekhraj S, Ripley DP, Rose K, Scheuermann-Freestone M, Schofield R, Sultan A. Real-world performance and accuracy of stress echocardiography: the EVAREST observational multi-centre study. Eur Heart J Cardiovasc Imaging. 2022 Apr 18;23(5):689-698. doi: 10.1093/ehjci/jeab092.

  PMID: 34148078 BACKGROUND

• Kadoglou NPE, Papadopoulos CH, Papadopoulos KG, Karagiannis S, Karabinos I, Loizos S, Theodosis-Georgilas A, Aggeli K, Keramida K, Klettas D, Kounas S, Makavos G, Ninios I, Ntalas I, Ikonomidis I, Sahpekidis V, Stefanidis A, Zaglavara T, Athanasopoulos G, Karatasakis G, Kyrzopoulos S, Kouris N, Patrianakos A, Paraskevaidis I, Rallidis L, Savvatis K, Tsiapras D, Nihoyannopoulos P. Updated knowledge and practical implementations of stress echocardiography in ischemic and non-ischemic cardiac diseases: An expert consensus of the Working Group of Echocardiography of the Hellenic Society of Cardiology. Hellenic J Cardiol. 2022 Mar-Apr;64:30-57. doi: 10.1016/j.hjc.2021.07.006. Epub 2021 Jul 28.

  PMID: 34329766 BACKGROUND

• Zhuravleva OA, Ryabova TR, Vrublevsky AV, Svyazova NN, Margolis NY, Boshchenko AA. Stress Echocardiography by the ABCDE Protocol ln the Assessment of Prognosis of Stable Coronary Heart Disease. Kardiologiia. 2024 Apr 30;64(4):22-30. doi: 10.18087/cardio.2024.4.n2572. English, Russian.

  PMID: 38742512 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Nikolaos Kadoglou

  University of Cyprus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaos Kadoglou

CONTACT

+306973275750; nikoskad@yahoo.com

Ioanna Metaxa

CONTACT

imetaxa@hcs.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 21, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)