Cardiovascular DiseasesNCT06265714
The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia
An observational study of Cardiovascular Diseases and Acute Coronary Syndrome, run by Universitas Indonesia at 9 sites in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Acute Coronary Syndrome, Heart Failure
- How many people
- 12,950 participants
- Where
- 9 sitesIndonesia
- Study dates
- 23 Jul 2021to 23 Sep 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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
Study population: The inclusion criteria of this study include patients aged ≥ 18 years old who consent to participate in the study. We exclude admissions solely for postoperative management following cardiac surgery. Patients willing to participate in this study are followed up on their day three and five of in-ICCU care, their hospital discharge time, and day 30 following the day of their hospital discharge. Patients who were admitted to the ICCU and meet the inclusion criteria will be informed regarding the details of this study. In cases where patients cannot express their consent to participate in this study (e.g., those with loss of consciousness), informed consent may be obtained from the patients' guardians on their behalf.
Who may be able to join
- Patients admitted to the ICCU
- Aged 18 years or older
- Provide consent to participate in the study
Who cannot join
- Postoperative management following cardiac surgery
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Indonesia9 sites
Prof. dr. I.G.N.G. Ngoerah General Hospital
Denpasar, Bali
National Cardiovacular Center Harapan Kita
Jakarta
Dr. Wahidin Sudirohusodo General Hospital
Makassar, South Sulawesi
Dr. Saiful Anwar General Hospital
Malang, East Java
Prof. Dr. R. D. Kandou Manado General Hospital
Manado, North Sulawesi
Dr. M. Djamil Padang General Hospital
Padang, West Sumatra
Dr. Kariadi General Hospital
Semarang, Central Java
Dr. Iskak General Hospital
Tulungagung, East Java
Sardjito General Hospital
Yogyakarta
About this study
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.
Read the detailed 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.
- Conditions
- Cardiovascular Diseases, Acute Coronary Syndrome, Heart Failure, Heart Disease, Coronary, Infections, Sepsis
- Medical subject headings
- Cardiovascular Diseases, Acute Coronary Syndrome, Heart Failure, Coronary Disease, Infections, Sepsis, Stroke, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| One ICCU Registry | The cohort was observed receiving all the necessary treatment in the ICCU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alive
Patient alive after being treated in ICCU.
Measured: 1 to 30 days
Death
Patient death after being treated in ICCU.
Measured: 1 to 30 days
Readmitted to ICCU
If a patient is readmitted to the ICCU after being transferred to a regular ward.
Measured: 1 to 30 days
Rehospitalization
Readmission to the hospital within 30 days of discharge after treatment.
Measured: 1 to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start23 Jul 2021
- Primary completion6 Sep 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,950 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dafsah A. Juzar, MD, Universitas Indonesia
- Investigators
- Dafsah Juzar, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265714
- Sponsor's protocol ID
- LB.02.01/VII/005/KEP005/2022
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Metkus TS, Baird-Zars VM, Alfonso CE, Alviar CL, Barnett CF, Barsness GW, Berg DD, Bertic M, Bohula EA, Burke J, Burstein B, Chaudhry SP, Cooper HA, Daniels LB, Fordyce CB, Ghafghazi S, Goldfarb M, Katz JN, Keeley EC, Keller NM, Kenigsberg B, Kontos MC, Kwon Y, Lawler PR, Leibner E, Liu S, Menon V, Miller PE, Newby LK, O'Brien CG, Papolos AI, Pierce MJ, Prasad R, Pisani B, Potter BJ, Roswell RO, Sinha SS, Shah KS, Smith TD, Snell RJ, So D, Solomon MA, Ternus BW, Teuteberg JJ, van Diepen S, Zakaria S, Morrow DA. Critical Care Cardiology Trials Network (CCCTN): a cohort profile. Eur Heart J Qual Care Clin Outcomes. 2022 Oct 26;8(7):703-708. doi: 10.1093/ehjqcco/qcac055.
PubMed 36029517
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The IndONEsia ICCU Registry: a Multicenter Cohort of Intensive Cardiovascular Care Units Patients in Indonesia
- ClinicalTrials.gov ID
- NCT06265714
- Acronym / sponsor ID
- LB.02.01/VII/005/KEP005/2022
- Conditions
- Cardiovascular Diseases, Acute Coronary Syndrome, Heart Failure, Heart Disease, Coronary, Infections, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,950 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 6 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 20 Feb 2024 (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.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One ICCU Registry | – | –The cohort was observed receiving all the necessary treatment in the ICCU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion criteria of this study include patients aged ≥ 18 years old who consent to participate in the study. We exclude admissions solely for postoperative management following cardiac surgery. Patients willing to participate in this study are followed up on their day three and five of in-ICCU care, their hospital discharge time, and day 30 following the day of their hospital discharge. Patients who were admitted to the ICCU and meet the inclusion criteria will be informed regarding the details of this study. In cases where patients cannot express their consent to participate in this study (e.g., those with loss of consciousness), informed consent may be obtained from the patients' guardians on their behalf.
Key inclusion criteria (3 listed)
- Patients admitted to the ICCU
- Aged 18 years or older
- Provide consent to participate in the study
Key exclusion criteria (1 listed)
- Postoperative management following cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alive
Time frame: 1 to 30 days
Patient alive after being treated in ICCU.
Death
Time frame: 1 to 30 days
Patient death after being treated in ICCU.
Readmitted to ICCU
Time frame: 1 to 30 days
If a patient is readmitted to the ICCU after being transferred to a regular ward.
Rehospitalization
Time frame: 1 to 30 days
Readmission to the hospital within 30 days of discharge after treatment.
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 2024.
- Background: PubMed 36029517Metkus TS, Baird-Zars VM, Alfonso CE, Alviar CL, Barnett CF, Barsness GW, Berg DD, Bertic M, Bohula EA, Burke J, Burstein B, Chaudhry SP, Cooper HA, Daniels LB, Fordyce CB, Ghafghazi S, Goldfarb M, Katz JN, Keeley EC, Keller NM, Kenigsberg B, Kontos MC, Kwon Y, Lawler PR, Leibner E, Liu S, Menon V, Miller PE, Newby LK, O'Brien CG, Papolos AI, Pierce MJ, Prasad R, Pisani B, Potter BJ, Roswell RO, Sinha SS, Shah KS, Smith TD, Snell RJ, So D, Solomon MA, Ternus BW, Teuteberg JJ, van Diepen S, Zakaria S, Morrow DA. Critical Care Cardiology Trials Network (CCCTN): a cohort profile. Eur Heart J Qual Care Clin Outcomes. 2022 Oct 26;8(7):703-708. doi: 10.1093/ehjqcco/qcac055.
- 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.
Dafsah Juzar, MD principal investigator
Universitas Indonesia
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Acute Coronary Syndrome, run by Universitas Indonesia at 9 sites 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 3 inclusion and 1 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 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Alive (time frame: 1 to 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265714, which also lists 1 linked publication.
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 2024.