The Recovery of Cardiovascular Patients With Depression

February 17, 2021 updated by: Sara Medved, Klinički Bolnički Centar Zagreb

The Changes in Functional Recovery and Brain Neurotrophic Factor Six Months After Percutaneous Coronary Intervention in Cardiovascular Patients With Depression

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Psychiatric treatment with sertraline
Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of newly recognized depression in patients after PCI
Other Names:
  • Intervention I
No Intervention: Control
Cardiovascular patients after PCI without depressive symptoms and without the need for psychiatric intervention
Experimental: 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
Drug: Psychiatric treatment with escitalopram
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
Other Names:
  • Intervention II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
baseline, six months
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.
baseline, six months
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.
baseline, six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months
Time Frame: baseline, six month
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.
baseline, six month
Change from Baseline The Global Registry of Acute Coronary Events (GRACE ACS Risk Model) at 6 months
Time Frame: baseline, six months
Changes in GRACE ACS Risk Model of cardiovascular patients six months after PCI
baseline, six months
Change from Baseline Duke Activity Status Index (DASI) at 6 months
Time Frame: baseline, six 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.
baseline, six months
Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months
Time Frame: baseline, six 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.
baseline, six months
Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months
Time Frame: baseline, six months
Changes in the serum levels of BDNF six months after PCI in cardiovascular patients without and cardiovascular patients with depressive symptoms
baseline, six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinički Bolnički Centar Zagreb

Investigators

  • Study Chair: Alma Mihaljević Peleš, Prof., Head of Department of Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

January 13, 2019

First Submitted That Met QC Criteria

February 12, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KBC Zagreb CoroDep

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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