Acute Coronary SyndromeSupportiveNCT04274205
Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome in Intensive Cardiac Care Unit
A study testing Intervention group in people with Acute Coronary Syndrome and Brief Supportive Psychotherapy, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
There was no MACE in both groups, but there was stroke-major adverse vascular event lower in brief supportive psychotherapy group. There was neutrophil-lymphocytes ratio change better in brief supportive psychotherapy group and significantly in acute coronary syndrome patients without chronic heart failure or coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Brief Supportive Psychotherapy, Intensive Cardiac Care Unit
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 18 Apr 2019to 30 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute coronary syndrome
- 》 18 years old
- have got pharmacological treatment in cardiology standard with or without anxiolytic drug and had got or had not yet got PCI
- be able to communicate and ready to have interview, fill the questioners and psychotherapy
Who cannot join
- stroke
- cardiogenic shock at admission time
- psychosis
- reject to involve in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome Patients in Intensive Cardiac Care Unit
There was no MACE in both groups, but there was stroke-major adverse vascular event lower in brief supportive psychotherapy group. There was neutrophil-lymphocytes ratio change better in brief supportive psychotherapy group and significantly in acute coronary syndrome patients without chronic heart failure or coronary arterial disease, also there was psychological symptom (depression) change better in brief supportive psychotherapy and significantly in acute coronary syndrome patients with chronic heart failure or coronary arterial disease.
- Being tested
- Intervention group
- Keywords
- Brief supportive psychotherapy, acute coronary syndrome, major adverse cardiovascular events, neutrophil-lymphocytes ratio, psychological symptoms
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
Also called Control group
Brief supportive psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Influence on brief supportive psychotherapy | Active comparator | Intervention group Receives: Other: Intervention group |
| Influence of brief supportive psychotherapy | Active comparator | Control group Receives: Other: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Fatal arrhytmia, recurrent myocardial infarction, cardiogenic shock, death
Measured: 5 days
Secondary outcomes (2)
Neutrophil-lymphocytes ratio
Pre-post measure
Measured: 5 days
Psychological symptoms (Hospital anxiety depression scale)
Pre-post measure
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start18 Apr 2019
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups Acute coronary syndrome group who got brief psychotherapy in five session in 5 days.. 30 minutes in 1 session Acute coronary syndrome group who did not get brief supportive psychotherapy as control Double opened RCT
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamzah Shatri, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274205
- Sponsor's protocol ID
- KET-177/UN2.F1/ETIK/PPM.00.02/
- Acronym
- Supportive
- Status last verified
- Feb 2020
- First submitted
- 14 Feb 2020
- Last updated
- 20 Feb 2020
- 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 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Brief Supportive Psychotherapy on Major Adverse Cardiovascular Events, Neutrophil-lymphocytes Ratio and Psychological Symptoms in Acute Coronary Syndrome Patients in Intensive Cardiac Care Unit
- ClinicalTrials.gov ID
- NCT04274205
- Acronym / sponsor ID
- Supportive / KET-177/UN2.F1/ETIK/PPM.00.02/
- Keywords
- Brief supportive psychotherapy, acute coronary syndrome, major adverse cardiovascular events, neutrophil-lymphocytes ratio, psychological symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 18 Feb 2020 (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.
There was no MACE in both groups, but there was stroke-major adverse vascular event lower in brief supportive psychotherapy group. There was neutrophil-lymphocytes ratio change better in brief supportive psychotherapy group and significantly in acute coronary syndrome patients without chronic heart failure or coronary arterial disease, also there was psychological symptom (depression) change better in brief supportive psychotherapy and significantly in acute coronary syndrome patients with chronic heart failure or coronary arterial disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups Acute coronary syndrome group who got brief psychotherapy in five session in 5 days.. 30 minutes in 1 session Acute coronary syndrome group who did not get brief supportive psychotherapy as control Double opened RCT
| Arm | Type | Receives |
|---|---|---|
| Influence on brief supportive psychotherapy | Active comparator | Other: Intervention groupIntervention group |
| Influence of brief supportive psychotherapy | Active comparator | Other: Intervention groupControl group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute coronary syndrome
- 》 18 years old
- have got pharmacological treatment in cardiology standard with or without anxiolytic drug and had got or had not yet got PCI
- be able to communicate and ready to have interview, fill the questioners and psychotherapy
Key exclusion criteria (4 listed)
- stroke
- cardiogenic shock at admission time
- psychosis
- reject to involve in study
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 |
|---|---|---|
| Intervention groupAlso: Control groupBrief supportive psychotherapy | Other | Influence of brief supportive psychotherapy, Influence on brief supportive psychotherapy |
Primary outcome
Major adverse cardiovascular events
Time frame: 5 days
Fatal arrhytmia, recurrent myocardial infarction, cardiogenic shock, death
2 secondary outcomes
Neutrophil-lymphocytes ratio
Time frame: 5 days
Psychological symptoms (Hospital anxiety depression scale)
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Acute Coronary Syndrome and Brief Supportive Psychotherapy, run by Universitas Indonesia at 1 site in Indonesia.
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 4 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: finished, as of the sponsor's last update on 20 Feb 2020. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: 5 days). 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 20 Feb 2020.