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The Recovery of Cardiovascular Patients With Depression

Primary Purpose

Coronary Artery Disease, Depression, Cardiovascular Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
Psychiatric treatment with sertraline
Psychiatric treatment with escitalopram
Sponsored by
Klinički Bolnički Centar Zagreb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Brain derived neurotrophic factor, BDNF, Psychosocial indicators, Depression, Cardiovascular disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • KBC ZagrebRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Intervention I

Control

Intervention II

Arm 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

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

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

Outcomes

Primary Outcome Measures

Change from Baseline Montgomery Asberg Depression Scale (MADRS) at 6 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 Hamilton Rating Scale for Depression (HAM-D) at 6 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.
Change from Baseline Beck Depression Inventory (BDI) at 6 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.

Secondary Outcome Measures

Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months
EQ-5D is a standardized instrument for measuring generic health status. Questionnaire has five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and all dimensions are described by 3 problem levels corresponding to patient response choices. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale.
Change from Baseline The Global Registry of Acute Coronary Events (GRACE ACS Risk Model) at 6 months
Changes in GRACE ACS Risk Model of cardiovascular patients six months after PCI
Change from Baseline Duke Activity Status Index (DASI) at 6 months
The Duke Activity Status Index (DASI) is an a 12-item questionnaire assessment tool used to evaluate the functional capacity of patients with cardiovascular disease. Each item has a specific weight based on the metabolic cost. The final score ranges between zero and 58.2 points. The higher the score indicates better functional capacity.
Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months
SAQ is a 19-item instrument that measures patient-reported symptoms, function and quality of life for patients with coronary artery disease. The answers patients give to the SAQ's questions are used to calculate scores in five scales: anginal stability, anginal frequency, physical limitation, treatment satisfaction and quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better functioning.
Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months
Changes in the serum levels of BDNF six months after PCI in cardiovascular patients without and cardiovascular patients with depressive symptoms

Full Information

First Posted
January 13, 2019
Last Updated
February 17, 2021
Sponsor
Klinički Bolnički Centar Zagreb
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1. Study Identification

Unique Protocol Identification Number
NCT03841474
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Klinički Bolnički Centar Zagreb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Depression, Cardiovascular Diseases
Keywords
Brain derived neurotrophic factor, BDNF, Psychosocial indicators, Depression, Cardiovascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention I
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Cardiovascular patients after PCI without depressive symptoms and without the need for psychiatric intervention
Arm Title
Intervention II
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Psychiatric treatment with sertraline
Other Intervention Name(s)
Intervention I
Intervention Description
Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of newly recognized depression in patients after PCI
Intervention Type
Drug
Intervention Name(s)
Psychiatric treatment with escitalopram
Other Intervention Name(s)
Intervention II
Intervention Description
Psychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of newly recognized depression in patients after PCI
Primary Outcome Measure Information:
Title
Change from Baseline Montgomery Asberg Depression Scale (MADRS) at 6 months
Description
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).
Time Frame
baseline, six months
Title
Change from Baseline Hamilton Rating Scale for Depression (HAM-D) at 6 months
Description
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.
Time Frame
baseline, six months
Title
Change from Baseline Beck Depression Inventory (BDI) at 6 months
Description
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.
Time Frame
baseline, six months
Secondary Outcome Measure Information:
Title
Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months
Description
EQ-5D is a standardized instrument for measuring generic health status. Questionnaire has five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and all dimensions are described by 3 problem levels corresponding to patient response choices. In the evaluation part, the respondents evaluate their overall health status using the visual analogue scale.
Time Frame
baseline, six month
Title
Change from Baseline The Global Registry of Acute Coronary Events (GRACE ACS Risk Model) at 6 months
Description
Changes in GRACE ACS Risk Model of cardiovascular patients six months after PCI
Time Frame
baseline, six months
Title
Change from Baseline Duke Activity Status Index (DASI) at 6 months
Description
The Duke Activity Status Index (DASI) is an a 12-item questionnaire assessment tool used to evaluate the functional capacity of patients with cardiovascular disease. Each item has a specific weight based on the metabolic cost. The final score ranges between zero and 58.2 points. The higher the score indicates better functional capacity.
Time Frame
baseline, six months
Title
Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months
Description
SAQ is a 19-item instrument that measures patient-reported symptoms, function and quality of life for patients with coronary artery disease. The answers patients give to the SAQ's questions are used to calculate scores in five scales: anginal stability, anginal frequency, physical limitation, treatment satisfaction and quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better functioning.
Time Frame
baseline, six months
Title
Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months
Description
Changes in the serum levels of BDNF six months after PCI in cardiovascular patients without and cardiovascular patients with depressive symptoms
Time Frame
baseline, six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Medved, MD
Phone
+38512388394
Email
smedved@kbc-zagreb.hr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alma Mihaljević Peleš, Prof.
Organizational Affiliation
Head of Department of Psychiatry
Official's Role
Study Chair
Facility Information:
Facility Name
KBC Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Medved, MD
Phone
+38512388394
Email
smedved@kbc-zagreb.hr

12. IPD Sharing Statement

Plan to Share IPD
No

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The Recovery of Cardiovascular Patients With Depression

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