The Role of Glycocalyx Integrity in the Primary Prevention of Major Cardiovascular Events

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity of Athens

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

History of Coronary artery disease,

History of Peripheral Arterial Disease,

History of Heart failure

History of Stroke

Trial population

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..

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Perfused Boundary Region of sublingual microvessels

    Other intervention

    Measurement of Perfused Boundary Region of sublingual microvessels to assess thickness of endothelial glycocalyx Measurement of Pulse Wave Velocity to quantify arterial stiffness

Treatment groups

No treatment groups listed

Trial outcomes

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).

Time frame
6 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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