The Recovery of Cardiovascular Patients With Depression

Klinički Bolnički Centar Zagreb

Status: Unknown

Conditions: Coronary Artery Disease; Cardiovascular Diseases; Depression

Treatments: Drug: Psychiatric treatment with sertraline; Drug: Psychiatric treatment with escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT03841474

KBC Zagreb CoroDep

Details and patient eligibility

About

Cardiovascular disease increases the risk of depression and vice versa. Many cardiovascular patients are subjected to percutaneous coronary intervention (PCI). Potential biomarkers for the development, the course and the recovery of both diseases are in the focus of interest of many studies. One of the biomarkers that stands out is brain derived neurotrophic factor (BDFN). BDNF plays a significant role in regulating vascular growth and repair but also stimulates the survival, differentiation, and conservation of neurons.

The aim of the study is to detect the depression in patients undergoing PCI and to determine the impact of psychiatric treatment on the functional recovery and on the changes of BDNF.

Full description

It has been shown that cardiovascular disease increases the risk of depression and vice versa. A significant proportion of cardiovascular diseases are coronary artery disease; most of these patients are subjected to percutaneous coronary intervention (PCI). That population of patients, which is under greater risk of depression, has been passing through the health system without adequate management of psychiatric difficulties. Despite the abundance of the data regarding the concomitancy of cardiovascular disease and depression, potential biomarkers for the development, the course and the recovery of both diseases are still in the focus of interest of many studies. One of the biomarkers that stands out is brain derived neurotrophic factor (BDFN). BDNF plays a significant role in regulating vascular growth and repair but also stimulates the survival, differentiation, and conservation of neurons. Its' serum level is reduced in cardiac failure and acute coronary syndrome, and indicates a higher risk of coronary incident in angina pectoris. BDNF is also reduced in depression, but increases during a pharmacological treatment along with the clinical improvement.

Therefore the aim of the study is to detect the occurrence of depression in patients undergoing PCI and to determine the impact of psychiatric treatment on the functional recovery of those patient and the correlation with the changes of serum levels of BDNF.

This represents the objectivization of the tertiary type of prevention intervention for recovery of cardiovascular patients who are currently passing through the investigator's health system with unrecognized psychiatric comorbidity.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients on day of percutaneous coronary intervention due to angina pectoris or myocardial infarction
• without antidepressant drugs or major tranquilizers more than one year

Exclusion criteria

• symptoms of myocardial infarction lasting more than 12 hours
• left ventricle ejection function (LVEF) less than 40%
• earlier presence of cardiomyopathy
• acute infection

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Intervention I

Experimental group

Description:

Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of cardiovascular patients after PCI with mild, moderate or severe depression

Treatment:

Drug: Psychiatric treatment with sertraline

Control

No Intervention group

Description:

Cardiovascular patients after PCI without depressive symptoms and without the need for psychiatric intervention

Intervention II

Experimental group

Description:

Psychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of cardiovascular patients after PCI with mild, moderate or severe depression

Treatment:

Drug: Psychiatric treatment with escitalopram