Coronary Artery DiseaseNCT03841474
The Recovery of Cardiovascular Patients With Depression
A study testing Psychiatric treatment with sertraline and Psychiatric treatment with escitalopram in people with Coronary Artery Disease and Depression, run by Klinički Bolnički Centar Zagreb at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Depression, Cardiovascular Diseases
- What is being tested?
- Psychiatric treatment with sertraline and Psychiatric treatment with escitalopram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Mar 2021to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients on day of percutaneous coronary intervention due to angina pectoris or myocardial infarction
- without antidepressant drugs or major tranquilizers more than one year
Who cannot join
- symptoms of myocardial infarction lasting more than 12 hours
- left ventricle ejection function (LVEF) less than 40%
- earlier presence of cardiomyopathy
- acute infection
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
KBC Zagreb
Zagreb, 10000
Sara Medved, MD, +38512388394, smedved@kbc-zagreb.hr
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease, Depression, Cardiovascular Diseases
- Being tested
- Psychiatric treatment with sertraline, Psychiatric treatment with escitalopram
- Keywords
- Brain derived neurotrophic factor, BDNF, Psychosocial indicators, Depression, Cardiovascular disease
- Medical subject headings
- Coronary Artery Disease, Depression, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric treatment with sertralineDrug
Also called Intervention I
Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of newly recognized depression in patients after PCI
Psychiatric treatment with escitalopramDrug
Also called Intervention II
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention I | Experimental | 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 Receives: Drug: Psychiatric treatment with sertraline |
| Control | No intervention | Cardiovascular patients after PCI without depressive symptoms and without the need for psychiatric intervention |
| Intervention II | Experimental | 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 Receives: Drug: Psychiatric treatment with escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, six months
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.
Measured: baseline, six months
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.
Measured: baseline, six months
Secondary outcomes (5)
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.
Measured: baseline, six month
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
Measured: baseline, six months
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.
Measured: baseline, six months
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.
Measured: baseline, six months
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
Measured: baseline, six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Mar 2021 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinički Bolnički Centar Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Medved, Klinički Bolnički Centar Zagreb
- Investigators
- Alma Mihaljević Peleš, Prof., Study chair, Head of Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841474
- Sponsor's protocol ID
- KBC Zagreb CoroDep
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2019
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Changes in Functional Recovery and Brain Neurotrophic Factor Six Months After Percutaneous Coronary Intervention in Cardiovascular Patients With Depression
- ClinicalTrials.gov ID
- NCT03841474
- Acronym / sponsor ID
- KBC Zagreb CoroDep
- Conditions
- Coronary Artery Disease, Depression, Cardiovascular Diseases
- Keywords
- Brain derived neurotrophic factor, BDNF, Psychosocial indicators, Depression, Cardiovascular disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Klinički Bolnički Centar ZagrebUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention I | Experimental | Drug: Psychiatric treatment with sertralinePsychiatric 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 |
| Control | No intervention | –Cardiovascular patients after PCI without depressive symptoms and without the need for psychiatric intervention |
| Intervention II | Experimental | Drug: Psychiatric treatment with escitalopramPsychiatric 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients on day of percutaneous coronary intervention due to angina pectoris or myocardial infarction
- without antidepressant drugs or major tranquilizers more than one year
Key exclusion criteria (4 listed)
- symptoms of myocardial infarction lasting more than 12 hours
- left ventricle ejection function (LVEF) less than 40%
- earlier presence of cardiomyopathy
- acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric treatment with sertralineAlso: Intervention IPsychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of newly recognized depression in patients after PCI | Drug | Intervention I |
| Psychiatric treatment with escitalopramAlso: Intervention IIPsychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of newly recognized depression in patients after PCI | Drug | Intervention II |
Primary outcome
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 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.
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.
5 secondary outcomes
Change from Baseline EuroQol Group 3-level version instrument (EQ-5D-3L) at 6 months
Time frame: 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
Change from Baseline Duke Activity Status Index (DASI) at 6 months
Time frame: baseline, six months
Change from Baseline The Seattle Angina Questionnaire (SAQ-7) at 6 months
Time frame: baseline, six months
Changes of blood serum concentrations of brain derived neurotrophic factor (BDNF) at 6 months
Time frame: baseline, six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alma Mihaljević Peleš, Prof. study chair
Head of Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychiatric treatment with sertraline and Psychiatric treatment with escitalopram in people with Coronary Artery Disease and Depression, run by Klinički Bolnički Centar Zagreb at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Medved, MD (+38512388394, smedved@kbc-zagreb.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Montgomery Asberg Depression Scale (MADRS) at 6 months (time frame: baseline, six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.