The Role of Glycocalyx Integrity in the Primary Prevention of Major Cardiovascular Events
Impaired Endothelial Glycocalyx Predicts Adverse Outcome in Subjects Without Overt Cardiovascular Disease: a 6 Year Follow up Study
1 other identifier
observational
500
1 country
1
Brief Summary
The researchers intend to recruit individuals who are referred for a routine screening in the primary prevention outpatient clinic of Attikon University hospital, Athens According to institutional protocols, a detailed medical history for atherosclerotic risk factors and current medication is recorded and a baseline clinical examination is performed. Moreover fasting blood samples are drawn to diagnose the presence of diabetes mellitus and hyperlipidemia. Glycocalyx examination is performed at the same visit. The subjects are revaluated at one month and then followed up according to the attending physician's instructions. Pulse wave velocity and the rest pulse wave analysis parameters were also calculated to determine the additive predictive value for cardiovascular events beyond SCORE2. All subjects are followed up for adverse events (death, stroke, myocardial infarction, hospitalization for heart failure) for 6 years after enrollment via telephonic contact and planned appointment at the outpatient clinic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Longer than P75 for all trials
1 active site
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
January 10, 2013
CompletedFirst Submitted
Initial submission to the registry
November 22, 2020
CompletedFirst Posted
Study publicly available on registry
November 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 28, 2027
May 29, 2024
May 1, 2024
13.4 years
November 22, 2020
May 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Adverse Cardiovascular events
death of any cause, myocardial infarction (ICD-10: DI20-22), stroke (ICD-10: DI60-68; DG45) and hospitalization for heart failure (ICD-10: DI50-51; DI42; DI11).
6 years
Interventions
Measurement of Perfused Boundary Region of sublingual microvessels to assess thickness of endothelial glycocalyx Measurement of Pulse Wave Velocity to quantify arterial stiffness
Eligibility Criteria
As far as ethnicity is concerned, an individual is not considered Greek in case he/she was born abroad and also has at least a foreigner parent or he/she is born in Greece but both parents were foreigners. Inversely, a subject was considered Greek if they and simultaneously both parents were born in Greece..
You may qualify if:
- We recruit individuals who were referred for a routine screening in the primary prevention outpatient clinic of Attikon University hospital.
You may not qualify if:
- History of Coronary artery disease,
- History of Peripheral Arterial Disease,
- History of Heart failure
- History of Stroke
- hepatic failure
- renal failure,
- active neoplasia
- poorly controlled DM, defined as Hba1C\>7%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
"Attikon" University General Hospital
Athens, Attica, 12462, Greece
Related Publications (1)
Ikonomidis I, Thymis J, Simitsis P, Koliou GA, Katsanos S, Triantafyllou C, Kousathana F, Pavlidis G, Kountouri A, Polyzogopoulou E, Katogiannis K, Vlastos D, Kostelli G, Triantafyllidi H, Parissis J, Papadavid E, Lekakis J, Filippatos G, Lambadiari V. Impaired Endothelial Glycocalyx Predicts Adverse Outcome in Subjects Without Overt Cardiovascular Disease: a 6-Year Follow-up Study. J Cardiovasc Transl Res. 2022 Aug;15(4):890-902. doi: 10.1007/s12265-021-10180-2. Epub 2021 Oct 28.
PMID: 34713396DERIVED
Biospecimen
Aliquots of serum and plasma
Study Officials
- PRINCIPAL INVESTIGATOR
IGNATIOS IKONOMIDIS, PROFESSOR
National and Kapodistrian University of Athens
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 22, 2020
First Posted
November 27, 2020
Study Start
January 10, 2013
Primary Completion (Estimated)
June 20, 2026
Study Completion (Estimated)
May 28, 2027
Last Updated
May 29, 2024
Record last verified: 2024-05