NCT05791916

Brief Summary

This study seeks to investigate the clinical value of novel biomarkers and echocardiographic indices, including myocardial work parameters, in patients with first acute myocardial infarction. The relationship between novel echocardiographic indices with clinical data, biochemical data in different myocardial infarction types will be attempted. Prognostic implications of those indices will be explored.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2.8 years

First QC Date

March 18, 2023

Last Update Submit

February 25, 2024

Conditions

Keywords

Acute Coronary SyndromeMyocardial InfarctionEchocardiographyMyocardial WorkBiomarkers

Outcome Measures

Primary Outcomes (2)

  • Relationship between clinical, laboratory and echocardiographic biomarkers

    Clinical, laboratory, conventional and novel echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers.

    24 months

  • Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients

    Clinical, laboratory, and echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers. Different units of measure in this outcome do not represent different outcome measures. All clinical, laboratory and echocardiographic measurements will be evaluated separately in their own unit of measurement to assess potential prognostic biomarkers in patients with acute myocardial infarction. This does not render the measurement of each parameter a different clinical outcome.

    24 months

Secondary Outcomes (5)

  • All-cause mortality

    24 months

  • Cardiovascular mortality

    24 months

  • Heart Failure hospitalization

    24 months

  • Acute Coronary syndrome

    24 months

  • MACE

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will enroll consecutive patients admitted to the First Department of Cardiology of AHEPA University General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece with first Acute Myocardial Infarction with or without ST elevation, as defined by the Fourth Universal Definition of Myocardial Infarction.

You may qualify if:

  • Patients older than 18 years
  • Patients acutely admitted at the Department of Cardiology of AHEPA University General Hospital, Thessaloniki, Greece with Acute Myocardial Infarction, as those are defined by the Fourth Universal Definition of Myocardial Infarction.
  • Patients without known history of coronary artery disease

You may not qualify if:

  • Patients \< 18 years old at time of coronary angiography
  • Patients with a previous history of coronary artery disease and/or prior revascularization
  • Inability or refusal to provide informed consent
  • Subject is pregnant and/or breastfeeding or intends to become pregnant during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AHEPA University Hospital, Thessaloniki, Greece

Thessaloniki, Central Macedonia, 54621, Greece

RECRUITING

AHEPA University Hospital, Thessaloniki, Greece

Thessaloniki, Central Macedonia, 54621, Greece

RECRUITING

Related Publications (1)

  • Daios S, Anastasiou V, Moysidis DV, Didagelos M, Papazoglou AS, Stalikas N, Zegkos T, Karagiannidis E, Skoura L, Kaiafa G, Makedou K, Ziakas A, Savopoulos C, Kamperidis V. Prognostic Implications of Clinical, Laboratory and Echocardiographic Biomarkers in Patients with Acute Myocardial Infarction-Rationale and Design of the ''CLEAR-AMI Study''. J Clin Med. 2023 Sep 2;12(17):5726. doi: 10.3390/jcm12175726.

MeSH Terms

Conditions

Cardiovascular DiseasesMyocardial InfarctionAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Antonios Ziakas, MD, PhD

    School of Medicine, Aristotle University of Thessaloniki

    STUDY DIRECTOR
  • Christos Savopoulos, MD, PhD

    School of Medicine, Aristotle University of Thessaloniki

    STUDY CHAIR
  • Vasileios Kamperidis, MD, MSc, PhD

    School of Medicine, Aristotle University of Thessaloniki

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christos Savopoulos, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2023

First Posted

March 30, 2023

Study Start

March 10, 2022

Primary Completion

December 10, 2024

Study Completion

February 1, 2025

Last Updated

February 28, 2024

Record last verified: 2024-02

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