Understanding and managing cardiovascular disease and its effects

Prevention and Treatment of Cardiovascular Disease: Protocol for the Assessment of Psychological, Neuropsychological Implications and Associated Disorders in Cardiology Patients

Observational IRCCS Centro Neurolesi Bonino Pulejo · NCT06413823

This study looks at how heart disease affects people and their caregivers, especially in relation to mental health and overall quality of life, over two years.

Quick facts

Study typeObservational
Enrollment218 (estimated)
Ages45 Years to 85 Years
SexAll
SponsorIRCCS Centro Neurolesi Bonino Pulejo Academic / other
Locations1 site (Messina, Sicily)
Trial IDNCT06413823 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the interconnectedness of cardiovascular disease with various comorbidities, including cognitive deficits and psychological conditions such as anxiety and depression. Over a period of approximately 24 months, the study will evaluate the impact of cardiovascular disease on both patients and their caregivers, focusing on their overall health and quality of life. The research will involve a minimum of 218 patients diagnosed with chronic cardiovascular disease, assessing their functioning through standardized tests and psychoeducational interventions.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 45 to 85 with a confirmed diagnosis of chronic cardiovascular disease and no significant cognitive impairment.

Not a fit: Patients with severe psychiatric or neurological disorders, end-stage oncological disease, or severe uncorrectable visual impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the quality of life for patients with cardiovascular disease by identifying and addressing comorbid conditions.

How similar studies have performed: Other studies have shown success in addressing comorbidities associated with cardiovascular disease, making this approach both relevant and potentially impactful.

Eligibility criteria

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age between 45 and 85 years;

  * Confirmed diagnosis of cardiovascular disease;
  * Presence of chronic cardiovascular disease;
  * Absence of cognitive impairment or mild/moderate cognitive impairment (Mini Mental Score \>26);
  * Patient who has given informed consent personally or through Legal Representative

Exclusion Criteria:

* \- Presence of severe psychiatric and neurological disorders
* Presence of end-stage oncological disease.
* Severe visual impairment that cannot be corrected by dioptric lenses

Where this trial is running

Messina, Sicily

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Cardiovascular DiseaseCardiovascular diseaseneuropsychologicaldepressionanxietypsychoeducationdysphagiacaregiver
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.