Prevention and Treatment of Cardiovascular Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-09

Study Completion Date

2026-05-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In view of the close interrelationship between the various organs and systems of the body, which cannot be examined in a parceled fashion but rather as an integrated system, this study aims to consider the potential risks associated with cardiovascular disease.

By identifying additional, often underestimated, altered functions that may affect the patient's quality of life and interfere with the performance of daily activities, this research study aims to evaluate the patient's functioning in an integrated manner to achieve a holistic view of the health and well-being of the patient and caregiver.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Psychosocial Risk Factors in Stroke and Myocardial Infarction

NCT02824107

Myocardial Infarction Stroke

COMPLETED NA

Trajectory of Positive Psychological States in Patients With ACS

NCT02298296

Acute Coronary Syndrome

COMPLETED

Steroids and Microcirculation In Cardiac Surgery

NCT02798068

C.Surgical Procedure Cardiac

TERMINATED PHASE4

Anger Expression, Self-focus and Coronary Heart Disease Risk Factors

NCT00005244

Cardiovascular Diseases Heart Diseases Coronary Disease

COMPLETED

Depressive Symptoms After Cardiac Surgery

NCT06706323

Cardiovascular Diseases Coronary Artery Disease Heart Diseases +7 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study design is observational and is planned to last approximately 24 months. The overall duration will be related to the time required for enrollment of all planned subjects, data analysis and publication of results.

The study aims to analyze and investigate the most common comorbidities in patients with cardiovascular disease. In addition, a specific focus will be devoted to the caregiver, who plays a key role for the cardiopathic patient.

In detail, the objectives of the project are:

1. Evaluate the connection between cardiovascular disease and cognitive deficits;
2. Evaluate the main psychopathologies related to cardiovascular diseases (anxiety, depression);
3. Evaluate conditions and disorders associated with cardiovascular diseases (dysphagia, pneumophonic coordination disorders, respiratory sleep disorders);
4. Evaluate the effectiveness of psychoeducational intervention;
5. Evaluate the impact of cardiovascular disease on the caregiver.

A minimum of 218 patients recruited from those afferent at the U.O.S.D. Cardiology with NICU P.O. "Piemonte" in Messina will participate in the survey. Statistical power analysis was performed using G\*Power software for a linear regression test, assuming a slope (H1) of 0.2 with a significance level (α) of 0.05 and a power (1 - β) of 0.85. The primary outcome variable considered for the calculation is the result of the SF-12 (or SF-36) test as a summary index of the effectiveness of psychoeducation. The calculation indicated a sample of 218 subjects as adequate for the purpose of detecting the hypothesized effect.

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.

Each patient who is eligible for this study will be presented with the purpose of the study and will freely decide whether to join. Only after the patient, or his/her Legal Representative, has agreed to participate in the investigation and signed the informed consent, can the Investigator proceed with the planned activities, detailed below.

The patient's pathway should unfold as follows:

Each patient's clinical data will be shared from a database, accessible to study collaborators through previously assigned login credentials. After checking inclusion and exclusion criteria and signing informed consents, patients will be taken on.

1. Baseline Examination.

* Verification of inclusion and exclusion criteria;
* Collection of demographic data;
* Collection of the patient's clinical history;
* Collection of information about the history of specific pathology and comorbidities.

Thereafter, standardized tests for psychological, neuropsychological and associated clinical conditions will be administered. In addition, there will be at least one psychoeducation meeting that can also be conducted in groups. The following tests will be administered:
* SF 36 Questionnaire or SF 12 Questionnaire;
* MaugerI CaRdiac preventiOn-Questionnaire (MICRO-Q);
* Mini-mental state examnation (MMSE);
* Beck's Depression Inventory (BDI);
* Beck's Anxiety Inventory (BAI);
* Zarit Burden Inventory (ZBI);
* Eat-10 test for monitoring swallowing ability and/or Swallowing Disturbance Questionnaire (SDQ).
* STOPBANG questionnaire and/or 2ABN3M score;
* Voice assessment using GIRBAS Scale and VHI. Feasibility will be assessed by considering adherence to the monitoring program through testicular assessments that will be performed not only at the baseline visit (T0) but also at the six-month follow-up (T1).
2. Follow-up visit. For each patient, the assessment tests will be repeated at the same time as the periodic follow-up visits.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No