Clinical trial NCT03841474: The Recovery of Cardiovascular Patients With Depression
Official title: The Changes in Functional Recovery and Brain Neurotrophic Factor Six Months After Percutaneous Coronary Intervention in Cardiovascular Patients With Depression
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Depression
Cardiovascular Diseases
Keywords: Brain derived neurotrophic factor
BDNF
Psychosocial indicators
Depression
Cardiovascular disease
Lead sponsor: Klinički Bolnički Centar Zagreb
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned to intervention group if they have symptoms of depression, i.e. to control group if they do not show depressive symptoms.

A psychiatrist will then, according to clinical impression, prescribe either sertraline or escitalopram to intervention group (i.e. groups). Both groups (sertraline and escitalopram) will be described as one intervention group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Montgomery Asberg Depression Scale (MADRS) at 6 months
timeFrame: baseline, six months
measure: Change from Baseline Hamilton Rating Scale for Depression (HAM-D) at 6 months
timeFrame: baseline, six months
measure: Change from Baseline Beck Depression Inventory (BDI) at 6 months
timeFrame: baseline, six months
Secondary outcomes:
measure: Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months
timeFrame: baseline, six month
measure: Change from Baseline The Global Registry of Acute Coronary Events (GRACE ACS Risk Model) at 6 months
timeFrame: baseline, six months
measure: Change from Baseline Duke Activity Status Index (DASI) at 6 months
timeFrame: baseline, six months
measure: Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months
timeFrame: baseline, six months
measure: Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months
timeFrame: baseline, six months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: KBC Zagreb
Study officials:
affiliation: Head of Department of Psychiatry
name: Alma Mihaljević Peleš, Prof.
role: STUDY_CHAIR
References: