Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years

NCT03925844 | Unknown

• 1 other identifier: PI18/00522
• Study Type: observational
• Target: 965
• Locations: 1 country
• Sites: 1

Brief Summary

This study assesses whether people's cardiovascular risk influences cognitive performance in later years. To do this, the cardiovascular risk and cognitive performance of each patient will be evaluated at the beginning of the study and 5 years later.

Conditions

Risk Factor, Cardiovascular; Cognitive Decline

Keywords

Cardiovascular risk prediction models; Framingham risk function; FRESCO risk function; risk function; cognitive aging; prevention

Outcome Measures

Primary Outcomes (8)

• Change in the 37-item versión of the Mini-Mental State Examination score

  The 37 item Version of the Mini-Mental State Examination is a Spanish adapted version of the original MMSE by Folstein. It contains 37 items. Includes temporal and spatial orientation, memory, attention, calculus, language, object recognition, elementary commands and visuoconstructive capacity. The minimun score is 0 and the maximum score is 37 points. Higher values are considered a better outcome.

  Baseline and 5 years

• Change in the Clock-drawing test score

  The Clock-drawing test is a brief test that explores comprehension, concentration, visual memory and abstraction and visuoconstructive praxis. The subject is asked to draw a clock from memory on a blank sheet, including the numbers and hands at a fixed time. The minimum score is 0 and the maximum score is 4. Higher values are considered a better outcome. Performance time is recorded. A shorter time is considered a better outcome.

  Baseline and 5 years

• Change in the Center for Epidemiologic Studies Depression Scale (CES-D) score

  The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening instrument for depression, self-administared, which records depressive symptoms and their different manifestations in the last 7 days and each symptom is classified in four frequency levels. The score ranges from 20 to 80. Higher values are considered a worse outcome.

  Baseline and 5 years

• Change in the Semantic verbal fluency test score

  The Semantic verbal fluency test evaluates semantic memory, executive and verbal planning capabilities. It is used a shorter version that evaluates the number of elements in a category (animals). There is a minimum score of 0, there is not a maximun score. Higher values are considered a better outcome.

  Baseline and 5 years

• Change in the Six-object memory recall test score

  The Six-Object Memory Recall Tests shows six sheets with common objects and explores object recognition, immediate recall and delayed memory after 5 minutes. Both, object recognition, inmediate recall and delayed memory have a scale ranging from 0 to 6.Therefore, the total score has a minimun score of 0 and a maximum score of 18 points. Higher values are considered a better outcome.

  Baseline and 5 years

• Change in the Mental Function Index score

  The Mental Function Index is a questionnaire that evaluates 11 instrumental activities of daily life and competencies in the home and occupational and social functioning that is administered to a family member or caregiver. It explores 11 sections, each one with three levels of functionality. The minimum score is 0 and the maximum score is 33. Higher values are considered a worse outcome.

  Baseline and 5 years

• Change in the Trail Making Test score

  The Trail Making Test is a visuomotor integration test from which is collected the score, the number of mistakes and the performance time. The score ranges from 1 to 20. Higher values are considered a better outcome. A shorter performance time and fewer mistakes are considered a better outcome.

  Baseline and 5 years

• Change in the Word accentuation test score

  The Word accentuation test is a verbal intelligence test in which the participant reads 30 unusual words that are shown to him without tildes and whose accentuation he has to do correctly. The score ranges from 0 to 30. Higher values are considered a better outcome.

  Baseline and 5 years

Secondary Outcomes (1)

• New cases of cancer during the 5-years follow-up

  5 years

Interventions

Classification according to the cardiovascular risk OTHER

All patients are cognitively assessed at the beginning of the study and their cardiovascular risk is calculated. After 5 years of follow-up, patients are re-evaluated cognitively and their cardiovascular risk is recalculated.

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population comes from the cohort NEDICES 2. NEDICES 2 population comes from primary care physician´s lists.

You may qualify if:

• population aged 55 to 74 years from NEDICES 2 study
• to have signed informed consent
• to have done the neuropsicological assessment

You may not qualify if:

• to have a dementia diagnosis at baseline.

Sponsors & Collaborators

• Gerencia de Atención Primaria, Madrid: lead

Study Sites (1)

Gerencia Atencion Primaria

Madrid, 28033, Spain

Location

Related Publications (2)

• Hernandez-Gallego J, Llamas-Velasco S, Bermejo-Pareja F, Vega S, Tapias-Merino E, Rodriguez-Sanchez E, Boycheva E, Serrano JI, Gil-Garcia JF, Trincado R, Sanchez-Rodrigo JV, Cacho J, Contador I, Garcia-Ptacek S, Sierra-Hidalgo F, Cubo E, Carro E, Villarejo-Galende A, Garcia Garcia-Patino R, Benito-Leon J. Neurological Disorders in Central Spain, Second Survey: Feasibility Pilot Observational Study. JMIR Res Protoc. 2019 Jan 10;8(1):e10941. doi: 10.2196/10941.

  PMID: 30632964 BACKGROUND

• Tapias-Merino E, De Hoyos-Alonso MDC, Contador-Castillo I, Rodriguez-Sanchez E, Sanz-Cuesta T, Becerro-Munoz CM, Hernandez-Gallego J, Vega-Quiroga S, Bermejo-Pareja F; NEDICES2-RISK Group. Cardiovascular risk in subjects over 55 years of age and cognitive performance after five years. NEDICES2-RISK study. Study protocol. PLoS One. 2022 Nov 28;17(11):e0274589. doi: 10.1371/journal.pone.0274589. eCollection 2022.

  PMID: 36441718 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ester Tapias-Merino, MD

  Gerencia de Atención Primaria, Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical researcher

Study Record Dates

• First Submitted: March 24, 2019
• First Posted: April 24, 2019
• Study Start: January 1, 2014
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

ES (1)