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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Arterial Stiffness; Lifestyles; Persistent COVID-19

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Elena Navarro Matías; Phone Number: 923177831; Email: enavarro@saludcastillayleon.es
• Study Contact Backup: Name: Manuel Ángel Gómez Marcos; Phone Number: 923177831; Email: magomez@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37005
    • Recruiting
    • Primary Care Research Unit of Salamanca (APISAL)
    • Contact: Olaya Tamayo Morales; Phone Number: 923177831; Email: olayatm@usal.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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%.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Wave Velocity	Measurement by SphygmoCor System (meters/seg)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drinking habits	Measurement by a frequency alcohol questionnaire (units/day)	1 year
Carotid intima-media thickness (IMT)	Measurement by Sonosite Micromax Ultrasound (mm)	1 year
Cardio Ankle Vascular Index (CAVI)	Measurement by Vasera device 2000 (not units)	1 year
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
Physical Activity	World Questionnaire on Physical Activity (GPAQ)	1 year
Eating habits	Mediterranean Diet Adherence PREDIMED Questionnaire	1 year
Smoking	Measurement by a questionnaire of four questions adapted from the WHO MONICA study	1 year
Psychological factors	Goldberg Anxiety and Depression Scale	1 year

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Estimated): September 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: GRS2501/B/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No