Stroke Clinical Trial - The IndONEsia ICCU Registry: a Multicenter Cohort

Status Completed

Clinical Trial Summary

Patients in the Intensive Cardiovascular Care Unit (ICCU) often present with cardiovascular disease (CVD) issues accompanied by various non-cardiovascular conditions. However, a widely applicable scoring system to predict patient outcomes in the ICCU is lacking. Therefore, developing and validating scores for predicting ICCU patient outcomes are warranted. The aims of the IndONEsia ICCU (One ICCU) registry include developing an epidemiological registry of ICCU patients and establishing a multicentre research network to analyse patient outcomes.This nationwide multicenter cohort will capture data from patients receiving cardiovascular critical care treatment in 10 Indonesian hospitals with ICCU facilities. Recorded data will encompass demographic characteristics, physical examination findings at hospital and ICCU admission, diagnoses at ICCU admission, therapy, intervention, complications on days 3 and 5 of in-ICCU care, in-hospital outcomes, and 30-day outcomes. The One ICCU is a large, prospective registry describing the care process and advancing clinical knowledge in ICCU patients. It will serve as an investigational platform for predicting the mortality of ICCU patients.

Clinical Trial Description

This prospective cohort registry study protocol comprised all consecutive primary medical ICCU admissions across one speciality hospital and nine general hospitals in Indonesia. The participating hospitals include the specialized National Cardiovascular Center Harapan Kita in Jakarta and nine general hospitals: Dr. Sardjito General Hospital in Yogyakarta, Dr. Wahidin Sudirohusodo General Hospital in Makassar, H. Adam Malik General Hospital in Medan, Dr. Saiful Anwar General Hospital in Malang, Dr. M. Djamil General Hospital in Padang, Dr. Iskak General Hospital in Tulungagung, Prof. Ngoerah General Hospital in Denpasar, Prof. Dr. R. D. Kandou General Hospital Manado, and Dr. Kariadi General Hospital Semarang. Each participating hospital will contribute data for all consecutive medical ICCU admissions for a period of 2 years, from 2021 to 2023. The participating hospitals were carefully selected to represent all regions of Indonesia. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06265714
Study type	Observational [Patient Registry]
Source	Indonesia University
Contact
Status	Completed
Phase
Start date	July 23, 2021
Completion date	September 23, 2023

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms