Vascular Structure, Vascular Function and Vascular Aging in Adults Diagnosed With Persistent COVID

NCT ID: NCT05819840

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-09

Study Completion Date

2023-12-31

Brief Summary

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The ICOPER study aims to analyze the structure, vascular function, vascular aging and determining factors in 300 adults diagnosed with Persistent Covid in the field of Primary Health Care.

Detailed Description

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Objective: To analyze the structure, the vascular function, the vascular aging and the determining factors in adults with a diagnosis of Persistent Covid and the differences by gender.

Design: Cross-sectional descriptive observational study. Setting: The study will be carried out at the Salamanca Primary Care Research Unit (APISAL). Study Subjects: The study includes the basis of the Persistent Covid Monographic consultation in the Internal Medicine Service of the University Hospital of Salamanca and the subjects with the diagnosis of Persistent Covid in the MEDORA Primary Care clinical history. Thus, 300 subjects have been obtained who are diagnosed with Persistent Covid, who meet the diagnostic criteria established by the Spanish Society of General and Family Physicians and sign the informed consent.

Measurements: The variables reflected in the Integrated Assistance process for the Care of People Affected by SARS CoV-2 of the Junta de Castilla y León will be collected, to evaluate the functional status of the patient and persistent symptoms, their impact on activities of daily life and quality of life of patients with Persistent Covid and the perception of their health. Lifestyles (diet, physical activity, tobacco and alcohol), psychological factors and cognitive impairment will be collected using validated questionnaires, and physical activity will be objectively measured with a 7-day pedometer. Vascular structure and function will be analyzed by measuring the thickness of the carotid intima media (Sonosite Micromax); pulse wave analysis and carotid-femoral pulse wave velocity (VOPcf) (Sphygmocor System). Cardio Ankle Vascular Index (CAVI), ankle-brachial pulse wave velocity (VOPbt) and ankle-brachial index (Vasera VS-2000®). Vascular aging will be calculated using the 10 and 90 percentiles of the VOPcf and the VOPbt. Demographic, analytical variables and to assess retinal, cardiac, renal, cerebral vascular lesion and cardiovascular risk will be collected.

Conditions

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Persistent COVID-19 Quality of Life Lifestyles Arterial Stiffness

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* History of probable or confirmed SARS-CoV-2 infection, usually 3 months after onset, with symptoms that last at least 2 months and cannot be explained by an alternative diagnosis.
* Common symptoms should include fatigue, shortness of breath, and cognitive dysfunction, and an impact on daily functioning.

Exclusion Criteria

* Subjects in a terminal situation.
* Inability to travel to health centers.
* Presenting a history of cardiovascular disease (ischemic heart disease or cerebrovascular disease).
* Glomerular filtration rate of less than 30%.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundacion para la Investigacion y Formacion en Ciencias de la Salud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Primary Care Research Unit of Salamanca (APISAL)

Salamanca, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Elena Navarro Matías

Role: CONTACT

923177831

Manuel Ángel Gómez Marcos

Role: CONTACT

923177831

Facility Contacts

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Olaya Tamayo Morales

Role: primary

923177831

References

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Vicente-Gabriel S, Lugones-Sanchez C, Tamayo-Morales O, Vicente Prieto A, Gonzalez-Sanchez S, Conde Martin S, Gomez-Sanchez M, Rodriguez-Sanchez E, Garcia-Ortiz L, Gomez-Sanchez L, Gomez-Marcos MA; EVA-Adic Investigators Group. Relationship between addictions and obesity, physical activity and vascular aging in young adults (EVA-Adic study): a research protocol of a cross-sectional study. Front Public Health. 2024 Jan 26;12:1322437. doi: 10.3389/fpubh.2024.1322437. eCollection 2024.

Reference Type DERIVED
PMID: 38344236 (View on PubMed)

Gomez-Sanchez L, Tamayo-Morales O, Suarez-Moreno N, Bermejo-Martin JF, Dominguez-Martin A, Martin-Oterino JA, Martin-Gonzalez JI, Gonzalez-Calle D, Garcia-Garcia A, Lugones-Sanchez C, Gonzalez-Sanchez S, Jimenez-Gomez R, Garcia-Ortiz L, Gomez-Marcos MA, Navarro-Matias E; ICOPER investigators group. Relationship between the structure, function and endothelial damage, and vascular ageing and the biopsychological situation in adults diagnosed with persistent COVID (BioICOPER study). A research protocol of a cross-sectional study. Front Physiol. 2023 Sep 12;14:1236430. doi: 10.3389/fphys.2023.1236430. eCollection 2023.

Reference Type DERIVED
PMID: 37772064 (View on PubMed)

Other Identifiers

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GRS2501/B/22

Identifier Type: -

Identifier Source: org_study_id

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