Acute Coronary SyndromeNCT05622292
The Effectivity of the Mobile App "HARKIT I-Care" in Secondary Prevention in Post-ACS Patients
A study testing HARKIT I-Care Application in people with Acute Coronary Syndrome, run by National Cardiovascular Center Harapan Kita Hospital Indonesia at 1 site in Indonesia.
Trial summary
HARKIT I-Care is a mobile application developed by the National Cardiovascular Center Harapan Kita (NCCHK) to leverage patients in achieving their targets for the secondary prevention of cardiovascular diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- HARKIT I-Care Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jun 2022to 30 Jun 2023
- 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 (ACS) patients, either ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), or unstable angina pectoris (UAP) who have or have not undergone revascularization treatment
Who cannot join
- Does not have or know how to operate smartphone
- Unable to perform a smartphone due to hearing, vision, or cognitive impairment
- Withdrawn consent from the research
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
National Cardiovascular Center Harapan Kita Hospital Indonesia
Jakarta, 11420
Bambang Dwiputra, MD, FIHA, 021-5684085 ext. 2209, bambangdwiputra@gmail.com
Kevin Triangto, MD, 021-5684085 ext. 2209, kevintriangto14@gmail.com
About this study
Official title: The Effectivity of the Mobile App "HARKIT I-Care" in Secondary Prevention in Post Acute Coronary Syndrome Patients in National Cardiovascular Center Harapan Kita Hospital
HARKIT I-Care is a mobile application developed by the National Cardiovascular Center Harapan Kita (NCCHK) to leverage patients in achieving their targets for the secondary prevention of cardiovascular diseases. The application contains various features, including exercise tracking and reminder, medication reminder, and updated educational content on cardiovascular health. Additionally, patients can log and record their blood pressure, heart rate, smoking behavior, Quality of Life, and laboratory parameters such as blood sugar and cholesterol. Our research aims to investigate whether implementing this app in post-acute coronary syndrome patients could improve their survival rate, hospitalization rate, medication adherence, and Quality of Life, along with improving their laboratory parameters to be within desirable targets.
Read the detailed description
Design: This study is a single-blinded, randomized clinical trial conducted in the National Cardiovascular Center Harapan Kita, and aims to investigate the effect of the mobile application "HARKIT I-Care" on the morbidity and mortality of post-acute coronary syndrome patients.
Subjects: Post-ACS patients hospitalized at the National Cardiovascular Center who are willing to be a subject in this research and have signed the informed consent form. Eligible subjects will be recruited and randomized to two groups: I-Care and control. Subjects in the I-Care group will be instructed to download 'HARKIT I-Care' application on their smartphone. Subjects will then be taught how to use the application, including logging blood pressure, blood sugar, and cholesterol levels, making use of exercise and medication reminders, and where to access health information and teleconsultation. Subjects are instructed to log their health parameters regularly according to the guidebook that has been prepared beforehand. Subjects in the control group will receive education on medication compliance and health information at the beginning of the enrolment. Education was conducted by another research team not involved in assessing outcomes.
Randomization: We conducted stratified permutated block random sampling using a computer application. Stratification used were: (1) Gender: male and female, (2) Age: <65 and ≥65, and (3) Diagnosis: STEMI (ST-Elevation Myocardial Infarction), NSTEMI (Non-ST-segment Elevation Myocardial Infarction), and UAP (Unstable Angina Pectoris). Randomization was conducted using a computer app, and patient assignments were done using a sealed opaque envelope containing the assignment group. Randomization was conducted by a study statistician not involved in data collection. Outcome assessors were blinded to the treatment.
Statistical Analysis plan: We planned on conducting a survival analysis for MACE (major adverse cardiovascular events), cardiovascular mortality, all-cause mortality, and rehospitalization rate. We also intended to analyze the effect of HARKIT I-Care on medication compliance, laboratory parameters, smoking cessation and relapse, sodium consumption, and physical activity.
- Conditions
- Acute Coronary Syndrome
- Being tested
- HARKIT I-Care Application
- Keywords
- Acute Coronary Syndrome, Mobile Health, Secondary Prevention
- 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.
HARKIT I-Care ApplicationDevice
HARKIT I-Care Application is an application available in the google play store. The application is specifically developed for the secondary prevention of cardiovascular disease. The features included in the application are (1) Health information logging, (2) Health information education, and (3) Teleconsultation with a cardiologist. Information that can be logged includes smoking behavior, medications, weight, blood sugar level, blood pressure, cholesterol level, physical activity, and Quality of life. Educational content can be accessed by patients in the form of articles and short videos.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects in the control group will receive education on the day of enrolment in NCCHK. Subjects are instructed to take medications and conduct hospital visits as usual. |
| I-Care | Experimental | Subjects will be instructed to download the "HARKIT I-Care" app from the google play store on their smartphones. Then, they will be guided to create an account and explained how to use the application, including how to log their progress (laboratory parameters and exercise tracking) and how to see messages from their physician. All follow-ups regarding treatment progress, education, and reminders will be done through the app. Patients are directed to conduct hospital visits once per month, where patients will be prescribed cardiovascular medications according to their current condition. Receives: Device: HARKIT I-Care Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Event
Major Adverse Cardiovascular Event (MACE) is described as all cardiovascular deaths, myocardial infarction, stroke, heart failure hospitalization, and revascularization event
Measured: 6 months
All-Cause Mortality
All deaths, both cardiovascular mortality and non-cardiovascular mortality
Measured: 6 months
Cardiovascular Mortality
We defined Cardiovascular Mortality as all deaths, excluding deaths which etiology definitely was a non-cardiovascular etiology
Measured: 6 months
Rehospitalization
Rehospitalization is defined as all unplanned visits to the hospital, both to the emergency department or inpatient ward, with the diagnosis of cardiovascular diseases and related complications (bleeding, hypertension crisis, and hyperglycemia crisis). Events of the planned visit to the hospital are excluded.
Measured: 6 months
Secondary outcomes (17)
Smoking Cessation
Smoking cessation is defined as the number of patients who at the time of recruitment are active smokers and at the time of final follow up the patients have stopped smoking for at least one month
Measured: 6 months
Smoking Relapse
Smoking relapse is defined as patient who at the time of recruitment is an ex smoker (defined as at least 1 month smoke-free before the time of recruitment) but during follow up time picks up smoking again
Measured: 6 months
Total Cholesterol Level (mg/dL)
Total Cholesterol level (in mg/dL) is measured at NCCHK laboratory
Measured: 1, 3, and 6 months
HDL Level (mg/dL)
HDL level (in mg/dL) is measured at NCCHK laboratory
Measured: 1, 3, and 6 months
LDL Level (mg/dL)
LDL level (in mg/dL) is measured at NCCHK laboratory
Measured: 1, 3, and 6 months
Triglyceride Level (mg/dL)
Triglyceride level (in mg/dL) is measured at NCCHK laboratory
Measured: 1, 3, and 6 months
Blood Glucose Level (mg/dL)
Blood Glucose Level (in mg/dL) is measured at NCCHK laboratory, including fasting blood glucose and postprandial blood glucose
Measured: 1, 3, and 6 months
HbA1c (%)
HbA1c (in %) is measured at NCCHK laboratory
Measured: 1, 3, and 6 months
SF-36 Quality of Life Questionnaire
SF 36 is a questionnaire developed to assess the Quality of Life in patients. Each question is scored from 0-100 and transformed into different scales (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, emotional well-being, social functioning, pain, and general health).
Measured: 1, 3, and 6 months
Physical activity level
Physical activity level is measured using the International Physical Activity Questionnaire (IPAQ). The result of the questionnaire will be converted into MET minutes
Measured: 1, 3, and 6 months
Medication Adherence
Medication adherence is measured using Morisky Medication Adherence Scale (MMAS)-8 questionnaire. The questionnaire contained 8 items, and each subject scored 1-8. Interpretation of the questionnaire is as follows: 8=high adherence, 7=medium adherence, ≤6=low adherence
Measured: 1, 3, and 6 months
Heart Disease Fact Questionnaire (HDFQ)
HDFQ is a questionnaire measuring patient's knowledge regarding coronary heart disease risk factor
Measured: 1, 3, and 6 months
Sodium Consumption
Sodium consumption is measured using WHO STEPS questionnaire
Measured: 1, 3, and 6 months
Indirect Cost
Indirect cost is defined as the cost used for transportation, consumption, accommodation, and caregiver hiring purposes. The data is gathered from direct interviews with subjects using the standardized instrument that had been prepared. The components are transportation, consumption, medical devices purchase, house renovation to foster medical necessities, caregiver fees, and loss of opportunity cost (the wage that should have been received if the subject works)
Measured: 1, 3, and 6 months
Quality-adjusted Life Years (QALYs)
QALYs are defined as the measure of health outcomes used to discover the effect of the intervention toward cost-effective analysis. This measurement is calculated by estimating the years of life remaining for a patient following a particular treatment or intervention multiplied by the changes in health quality caused by the intervention using the EQ-5D-5L questionnaire.
Measured: 1, 3, and 6 months
Cost-Utility Analysis
Cost-utility analysis is defined as incremental cost-effectiveness ratio (ICER), which is the absolute value calculated from the differences in cost between intervention and control divided by the differences of outcomes yielded.
Measured: 1, 3, and 6 months
Direct Cost
Direct cost is defined as the cost for outpatient clinic visits, medications, supporting examinations, and interventional procedures (including percutaneous coronary intervention and coronary artery bypass graft). It is measured from data stored in the finance department and information system of the hospital.
Measured: 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Jun 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-blind, randomized, controlled clinical trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bambang Dwiputra, MD, National Cardiovascular Center Harapan Kita Hospital Indonesia
- Investigators
- Bambang Dwiputra, MD, FIHA, Principal investigator, National Cardiovascular Center Harapan Kita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622292
- Sponsor's protocol ID
- HARKIT I-Care
- Status last verified
- Feb 2023
- First submitted
- 13 Nov 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szekely O, Lane DA, Lip GYH. Guideline-adherent secondary prevention post-acute coronary syndromes: the importance of patient uptake and persistence. Eur Heart J. 2018 Jul 1;39(25):2365-2367. doi: 10.1093/eurheartj/ehy308. No abstract available.
PubMed 29878099Chow CK, Brieger D, Ryan M, Kangaharan N, Hyun KK, Briffa T. Secondary prevention therapies in acute coronary syndrome and relation to outcomes: observational study. Heart Asia. 2019 Jan 12;11(1):e011122. doi: 10.1136/heartasia-2018-011122. eCollection 2019.
PubMed 30728864Mathews R, Peterson ED, Honeycutt E, Chin CT, Effron MB, Zettler M, Fonarow GC, Henry TD, Wang TY. Early Medication Nonadherence After Acute Myocardial Infarction: Insights into Actionable Opportunities From the TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circ Cardiovasc Qual Outcomes. 2015 Jul;8(4):347-56. doi: 10.1161/CIRCOUTCOMES.114.001223. Epub 2015 Jun 2.
PubMed 26038524Park YT. Emerging New Era of Mobile Health Technologies. Healthc Inform Res. 2016 Oct;22(4):253-254. doi: 10.4258/hir.2016.22.4.253. Epub 2016 Oct 31. No abstract available.
PubMed 27895955Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018.
PubMed 29474713
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectivity of the Mobile App "HARKIT I-Care" in Secondary Prevention in Post Acute Coronary Syndrome Patients in National Cardiovascular Center Harapan Kita Hospital
- ClinicalTrials.gov ID
- NCT05622292
- Acronym / sponsor ID
- HARKIT I-Care
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Mobile Health, Secondary Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 Nov 2022 (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.
HARKIT I-Care is a mobile application developed by the National Cardiovascular Center Harapan Kita (NCCHK) to leverage patients in achieving their targets for the secondary prevention of cardiovascular diseases. The application contains various features, including exercise tracking and reminder, medication reminder, and updated educational content on cardiovascular health. Additionally, patients can log and record their blood pressure, heart rate, smoking behavior, Quality of Life, and laboratory parameters such as blood sugar and cholesterol. Our research aims to investigate whether implementing this app in post-acute coronary syndrome patients could improve their survival rate, hospitalization rate, medication adherence, and Quality of Life, along with improving their laboratory parameters to be within desirable targets.
Detailed description
Design: This study is a single-blinded, randomized clinical trial conducted in the National Cardiovascular Center Harapan Kita, and aims to investigate the effect of the mobile application "HARKIT I-Care" on the morbidity and mortality of post-acute coronary syndrome patients.
Subjects: Post-ACS patients hospitalized at the National Cardiovascular Center who are willing to be a subject in this research and have signed the informed consent form. Eligible subjects will be recruited and randomized to two groups: I-Care and control. Subjects in the I-Care group will be instructed to download 'HARKIT I-Care' application on their smartphone. Subjects will then be taught how to use the application, including logging blood pressure, blood sugar, and cholesterol levels, making use of exercise and medication reminders, and where to access health information and teleconsultation. Subjects are instructed to log their health parameters regularly according to the guidebook that has been prepared beforehand. Subjects in the control group will receive education on medication compliance and health information at the beginning of the enrolment. Education was conducted by another research team not involved in assessing outcomes.
Randomization: We conducted stratified permutated block random sampling using a computer application. Stratification used were: (1) Gender: male and female, (2) Age: <65 and ≥65, and (3) Diagnosis: STEMI (ST-Elevation Myocardial Infarction), NSTEMI (Non-ST-segment Elevation Myocardial Infarction), and UAP (Unstable Angina Pectoris). Randomization was conducted using a computer app, and patient assignments were done using a sealed opaque envelope containing the assignment group. Randomization was conducted by a study statistician not involved in data collection. Outcome assessors were blinded to the treatment.
Statistical Analysis plan: We planned on conducting a survival analysis for MACE (major adverse cardiovascular events), cardiovascular mortality, all-cause mortality, and rehospitalization rate. We also intended to analyze the effect of HARKIT I-Care on medication compliance, laboratory parameters, smoking cessation and relapse, sodium consumption, and physical activity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-blind, randomized, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects in the control group will receive education on the day of enrolment in NCCHK. Subjects are instructed to take medications and conduct hospital visits as usual. |
| I-Care | Experimental | Device: HARKIT I-Care ApplicationSubjects will be instructed to download the "HARKIT I-Care" app from the google play store on their smartphones. Then, they will be guided to create an account and explained how to use the application, including how to log their progress (laboratory parameters and exercise tracking) and how to see messages from their physician. All follow-ups regarding treatment progress, education, and reminders will be done through the app. Patients are directed to conduct hospital visits once per month, where patients will be prescribed cardiovascular medications according to their current condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acute Coronary Syndrome (ACS) patients, either ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), or unstable angina pectoris (UAP) who have or have not undergone revascularization treatment
Key exclusion criteria (3 listed)
- Does not have or know how to operate smartphone
- Unable to perform a smartphone due to hearing, vision, or cognitive impairment
- Withdrawn consent from the research
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 |
|---|---|---|
| HARKIT I-Care ApplicationHARKIT I-Care Application is an application available in the google play store. The application is specifically developed for the secondary prevention of cardiovascular disease. The features included in the application are (1) Health information logging, (2) Health information education, and (3) Teleconsultation with a cardiologist. Information that can be logged includes smoking behavior, medications, weight, blood sugar level, blood pressure, cholesterol level, physical activity, and Quality of life. Educational content can be accessed by patients in the form of articles and short videos. | Device | I-Care |
Primary outcome
Major Adverse Cardiovascular Event
Time frame: 6 months
Major Adverse Cardiovascular Event (MACE) is described as all cardiovascular deaths, myocardial infarction, stroke, heart failure hospitalization, and revascularization event
All-Cause Mortality
Time frame: 6 months
All deaths, both cardiovascular mortality and non-cardiovascular mortality
Cardiovascular Mortality
Time frame: 6 months
We defined Cardiovascular Mortality as all deaths, excluding deaths which etiology definitely was a non-cardiovascular etiology
Rehospitalization
Time frame: 6 months
Rehospitalization is defined as all unplanned visits to the hospital, both to the emergency department or inpatient ward, with the diagnosis of cardiovascular diseases and related complications (bleeding, hypertension crisis, and hyperglycemia crisis). Events of the planned visit to the hospital are excluded.
17 secondary outcomes
Smoking Cessation
Time frame: 6 months
Smoking Relapse
Time frame: 6 months
Total Cholesterol Level (mg/dL)
Time frame: 1, 3, and 6 months
HDL Level (mg/dL)
Time frame: 1, 3, and 6 months
LDL Level (mg/dL)
Time frame: 1, 3, and 6 months
Triglyceride Level (mg/dL)
Time frame: 1, 3, and 6 months
Blood Glucose Level (mg/dL)
Time frame: 1, 3, and 6 months
HbA1c (%)
Time frame: 1, 3, and 6 months
SF-36 Quality of Life Questionnaire
Time frame: 1, 3, and 6 months
Physical activity level
Time frame: 1, 3, and 6 months
Medication Adherence
Time frame: 1, 3, and 6 months
Heart Disease Fact Questionnaire (HDFQ)
Time frame: 1, 3, and 6 months
Sodium Consumption
Time frame: 1, 3, and 6 months
Indirect Cost
Time frame: 1, 3, and 6 months
Quality-adjusted Life Years (QALYs)
Time frame: 1, 3, and 6 months
Cost-Utility Analysis
Time frame: 1, 3, and 6 months
Direct Cost
Time frame: 1, 3, and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Background: PubMed 29878099Szekely O, Lane DA, Lip GYH. Guideline-adherent secondary prevention post-acute coronary syndromes: the importance of patient uptake and persistence. Eur Heart J. 2018 Jul 1;39(25):2365-2367. doi: 10.1093/eurheartj/ehy308. No abstract available.
- Background: PubMed 30728864Chow CK, Brieger D, Ryan M, Kangaharan N, Hyun KK, Briffa T. Secondary prevention therapies in acute coronary syndrome and relation to outcomes: observational study. Heart Asia. 2019 Jan 12;11(1):e011122. doi: 10.1136/heartasia-2018-011122. eCollection 2019.
- Background: PubMed 26038524Mathews R, Peterson ED, Honeycutt E, Chin CT, Effron MB, Zettler M, Fonarow GC, Henry TD, Wang TY. Early Medication Nonadherence After Acute Myocardial Infarction: Insights into Actionable Opportunities From the TReatment with ADP receptor iNhibitorS: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circ Cardiovasc Qual Outcomes. 2015 Jul;8(4):347-56. doi: 10.1161/CIRCOUTCOMES.114.001223. Epub 2015 Jun 2.
- Background: PubMed 27895955Park YT. Emerging New Era of Mobile Health Technologies. Healthc Inform Res. 2016 Oct;22(4):253-254. doi: 10.4258/hir.2016.22.4.253. Epub 2016 Oct 31. No abstract available.
- Background: PubMed 29474713Gandapur Y, Kianoush S, Kelli HM, Misra S, Urrea B, Blaha MJ, Graham G, Marvel FA, Martin SS. The role of mHealth for improving medication adherence in patients with cardiovascular disease: a systematic review. Eur Heart J Qual Care Clin Outcomes. 2016 Oct 1;2(4):237-244. doi: 10.1093/ehjqcco/qcw018.
- 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.
Bambang Dwiputra, MD, FIHA principal investigator
National Cardiovascular Center Harapan Kita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARKIT I-Care Application in people with Acute Coronary Syndrome, run by National Cardiovascular Center Harapan Kita Hospital 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 1 inclusion and 3 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 23 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bambang Dwiputra, MD (+6281371032882, bambangdwiputra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Event (time frame: 6 months). 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 NCT05622292, which also lists 5 linked publications.
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 23 Feb 2023.