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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04646252
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

Brief Summary:
We 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. 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.

Condition or disease Intervention/treatment
Endothelial Dysfunction Other: Perfused Boundary Region of sublingual microvessels

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impaired Endothelial Glycocalyx Predicts Adverse Outcome in Subjects Without Overt Cardiovascular Disease: a 6 Year Follow up Study
Actual Study Start Date : January 10, 2013
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : March 28, 2023

Intervention Details:
  • Other: Perfused Boundary Region of sublingual microvessels
    Measurement of Perfused Boundary Region of sublingual microvessels to assess thickness of endothelial glycocalyx


Primary Outcome Measures :
  1. Major Adverse Cardiovascular events [ Time Frame: 6 years ]
    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).


Biospecimen Retention:   Samples Without DNA
Aliquots of serum and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study 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..
Criteria

Inclusion Criteria:

We recruit individuals who were referred for a routine screening in the primary prevention outpatient clinic of Attikon University hospital.

Exclusion Criteria:

  • 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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646252


Contacts
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Contact: IGNATIOS IKONOMIDIS +30 2105832192 ignoik@gmail.com
Contact: John Thymis +306940617712 johnythg@gmail.com

Locations
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Greece
"Attikon" University General Hospital Recruiting
Athens, Attiki, Greece, 12462
Principal Investigator: Ignatios Ikonomidis, MD         
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: IGNATIOS IKONOMIDIS, PROFESSOR National and Kapodistrian University of Athens
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ignatios Ikonomidis, Professor, University of Athens
ClinicalTrials.gov Identifier: NCT04646252    
Other Study ID Numbers: Glycocalyx primary prevention
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ignatios Ikonomidis, University of Athens:
perfused boundary region
primary prevention of major cardiovascular events
integrity of endothelial glycocalyx