The Changes in Functional Recovery and Brain Neurotrophic Factor Six Months After Percutaneous Coronary Intervention in Cardiovascular Patients With Depression
Overview
- Phase
- Not Applicable
- Intervention
- Psychiatric treatment with sertraline
- Conditions
- Coronary Artery Disease
- Sponsor
- Klinički Bolnički Centar Zagreb
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change from Baseline Montgomery Asberg Depression Scale (MADRS) at 6 months
- Last Updated
- 5 years ago
Overview
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.
Investigators
Sara Medved
Principal Investigator
Klinički Bolnički Centar Zagreb
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
Arms & Interventions
Intervention I
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
Intervention: Psychiatric treatment with sertraline
Intervention II
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
Intervention: Psychiatric treatment with escitalopram
Outcomes
Primary Outcomes
Change from Baseline Montgomery Asberg Depression Scale (MADRS) at 6 months
Time Frame: baseline, six months
A 10-item clinician-administered questionnaire used to measure the severity of depressive symptoms in patients with mood disorders. Ten questions rate the severity of symptoms on scale of 0 (not present), 2 (mild), 4 (moderate), and 6 (severe).
Change from Baseline Beck Depression Inventory (BDI) at 6 months
Time Frame: baseline, six months
A 21-question multiple-choice self-report inventory, with each question having a set of four and more possible responses, ranging in intensity. A value of 0 to 3 is assigned for each answer and the total score represents the sum of the values. Higher total score indicates more severe depressive symptoms.
Change from Baseline Hamilton Rating Scale for Depression (HAM-D) at 6 months
Time Frame: baseline, six months
Semi-structured interview with 17 questions, designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. A score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
Secondary Outcomes
- Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months(baseline, six months)
- Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months(baseline, six month)
- Change from Baseline The Global Registry of Acute Coronary Events (GRACE ACS Risk Model) at 6 months(baseline, six months)
- Change from Baseline Duke Activity Status Index (DASI) at 6 months(baseline, six months)
- Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months(baseline, six months)