Clinical trial NCT05819840: Vascular Structure, Vascular Function and Vascular Aging in Adults Diagnosed With Persistent COVID
Official title: Vascular Structure, Vascular Function and Vascular Aging in Adults Diagnosed With Persistent COVID. ICOPER Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Persistent COVID-19
Quality of Life
Lifestyles
Arterial Stiffness
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Through consecutive sampling, 300 subjects will be selected who meet the WHO clinical definition of Persistent Covid established by international Delphi consensus. The subjects will be recruited from the existing records in the Primary Care consultations and in the Internal Medicine Persistent Covid consultation in the Salamanca health area.

Brief summary: 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: 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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Pulse Wave Velocity
timeFrame: 1 year
Secondary outcomes:
measure: Carotid intima-media thickness (IMT)
timeFrame: 1 year
measure: Cardio Ankle Vascular Index (CAVI)
timeFrame: 1 year
measure: Physical Activity
timeFrame: 1 year
measure: Eating habits
timeFrame: 1 year
measure: Smoking
timeFrame: 1 year
measure: Drinking habits
timeFrame: 1 year
measure: Psychological factors
timeFrame: 1 year
measure: Cognitive evaluation
timeFrame: 1 year
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Primary Care Research Unit of Salamanca (APISAL)
Study officials:
References: