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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04274205
Other study ID # KET-177/UN2.F1/ETIK/PPM.00.02/
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2019
Est. completion date July 30, 2019

Study information

Verified date February 2020
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date July 30, 2019
Est. primary completion date July 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- acute coronary syndrome

- ยป 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

Exclusion Criteria:

- stroke

- cardiogenic shock at admission time

- psychosis

- reject to involve in study

Study Design


Intervention

Other:
Intervention group
Brief supportive psychotherapy

Locations

Country Name City State
Indonesia Medical Faculty Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major adverse cardiovascular events Fatal arrhytmia, recurrent myocardial infarction, cardiogenic shock, death 5 days
Secondary Neutrophil-lymphocytes ratio Pre-post measure 5 days
Secondary Psychological symptoms (Hospital anxiety depression scale) Pre-post measure 5 days
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