ICOPER: Vascular Structure, Vascular Function and Vascular Aging in Adults Diagnosed With Persistent COVID
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Pulse Wave Velocity [1 year]
Measurement by SphygmoCor System (meters/seg)
Secondary Outcome Measures
- Carotid intima-media thickness (IMT) [1 year]
Measurement by Sonosite Micromax Ultrasound (mm)
- Cardio Ankle Vascular Index (CAVI) [1 year]
Measurement by Vasera device 2000 (not units)
- Physical Activity [1 year]
World Questionnaire on Physical Activity (GPAQ)
- Eating habits [1 year]
Mediterranean Diet Adherence PREDIMED Questionnaire
- Smoking [1 year]
Measurement by a questionnaire of four questions adapted from the WHO MONICA study
- Drinking habits [1 year]
Measurement by a frequency alcohol questionnaire (units/day)
- Psychological factors [1 year]
Goldberg Anxiety and Depression Scale
- Cognitive evaluation [1 year]
Measurement by Montreal Cognitive Assessment (MOCA) (points). Range: 0-30 points. A score of 26 points or above is considered normal.
Eligibility Criteria
Criteria
Inclusion Criteria:
The inclusion criteria are based on the WHO clinical definition of Persistent Covid established by international Delphi consensus, together with patients, their representatives and experts from the five continents. Persistent Covid is the condition of individuals with a 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 include fatigue, shortness of breath, and cognitive dysfunction, and generally have an impact on daily functioning. Symptoms may be of new onset after initial recovery from an acute episode of Covid-19 or persist from the initial illness. Symptoms may also fluctuate or relapse over time.
Exclusion Criteria:
As 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) or a glomerular filtration rate of less than 30%.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Primary Care Research Unit of Salamanca (APISAL) | Salamanca | Spain | 37005 |
Sponsors and Collaborators
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GRS2501/B/22