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

Quality of Life Clinical Trial

— ICOPER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819840
• Other study ID #: GRS2501/B/22
• Status: Recruiting
• Start date: March 9, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: Elena Navarro Matías
• Phone: 923177831
• Email: enavarro[@]saludcastillayleon.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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%.

Related Conditions & MeSH terms

• Arterial Stiffness
• Lifestyles
• Quality of Life

Locations

Country	Name	City	State
Spain	Primary Care Research Unit of Salamanca (APISAL)	Salamanca

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse Wave Velocity	Measurement by SphygmoCor System (meters/seg)	1 year
Secondary	Carotid intima-media thickness (IMT)	Measurement by Sonosite Micromax Ultrasound (mm)	1 year
Secondary	Cardio Ankle Vascular Index (CAVI)	Measurement by Vasera device 2000 (not units)	1 year
Secondary	Physical Activity	World Questionnaire on Physical Activity (GPAQ)	1 year
Secondary	Eating habits	Mediterranean Diet Adherence PREDIMED Questionnaire	1 year
Secondary	Smoking	Measurement by a questionnaire of four questions adapted from the WHO MONICA study	1 year
Secondary	Drinking habits	Measurement by a frequency alcohol questionnaire (units/day)	1 year
Secondary	Psychological factors	Goldberg Anxiety and Depression Scale	1 year
Secondary	Cognitive evaluation	Measurement by Montreal Cognitive Assessment (MOCA) (points). Range: 0-30 points. A score of 26 points or above is considered normal.	1 year