Acute Myocardial InfarctionNCT05974397
Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
An observational study of Acute Myocardial Infarction, run by Novartis Pharmaceuticals at 1 site in Taiwan.
Trial summary
This was a retrospective study using the Taiwan's National Health Insurance Research Database (NHIRD). The study employed two study designs for different purposes as follows: A cross-sectional analysis was conducted to explore the annual incidence trends. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 124,018 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2021to 22 Jul 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Cross-sectional analysis:
- Patients aged 20 years and older.
- Patients who had been admitted for AMI, defined as primary or first secondary diagnosis of AMI between 2014 and 2020.
- The diagnosis of AMI/ STEMI/ NSTEMI was identified by the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes and 10th revision (ICD-10-CM) codes.
- Incident cases of AMI hospitalization were defined as no history of AMI-related hospitalization or outpatient visit within 1 year before admission.
- Longitudinal analysis:
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- Patients aged 20 years and older.
- Patients who had been admitted for AMI, defined as primary or first secondary diagnosis of AMI between 2014 and 2017.
- The diagnosis of AMI/ STEMI/ NSTEMI was identified by ICD-9-CM codes and ICD-10-CM codes. (The ICD-9-CM code and ICD-10-CM codes were the same as above)
- Incident cases of AMI hospitalization were defined as no history of AMI-related hospitalization or outpatient visit within 1 year before admission.
- The cohort entry date was defined as the admission date of incident AMI hospitalization, and the index date was defined as the discharge date of incident hospitalization.
Who cannot join
- None specified
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective study using the Taiwan's National Health Insurance Research Database (NHIRD). The study employed two study designs for different purposes as follows:
- A cross-sectional analysis was conducted to explore the annual incidence trends.
- A longitudinal cohort study was conducted to assess baseline characteristics, treatment patterns, long-term healthcare utilization, and cause-specific mortality among incident AMI patients.
In each part, the study was conducted for AMI, and separately for ST-segment elevation and non-ST- segment elevation myocardial infarction (STEMI and NSTEMI)
- Conditions
- Acute Myocardial Infarction
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 |
|---|---|---|
| AMI | Patients with AMI | |
| STEMI | Patients with STEMI | |
| NSTEMI | Patients with NSTEMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean age of patients
Measured: 12 months
Number of male patients
Measured: 12 months
Year of patient entry into cohort
Measured: 12 months
Number of patients with AMI in Taiwan
Measured: 12 months
Number of patients with STEMI in Taiwan
Measured: 12 months
Number of patients with NSTEMI in Taiwan
Measured: 12 months
Number of AMI patients with comorbidities
Measured: Up to 3 years
Number of patients with treatment for AMI
Measured: Up to 3 years
Number of STEMI patients with comorbidities
Measured: Up to 3 years
Number of patients with treatment for STEMI
Measured: Up to 3 years
Number of NSTEMI patients with comorbidities
Measured: Up to 3 years
Number of patients with treatment for NSTEMI
Measured: Up to 3 years
Number of mortalities among AMI patients
Measured: Up to 3 years
Number of mortalities among STEMI patients
Measured: Up to 3 years
Number of mortalities among NSTEMI patients
Measured: Up to 3 years
Number of AMI patients with outpatient visits
Measured: Up to 3 years
Number of AMI patients with emergency room visits
Measured: Up to 3 years
Number of AMI patients with hospitalizations
Measured: Up to 3 years
Length of hospital stay for AMI patients
Measured: Up to 3 years
Direct medical costs for AMI patients
Measured: Up to 3 years
Number of STEMI patients with outpatient visits
Measured: Up to 3 years
Number of STEMI patients with emergency room visits
Measured: Up to 3 years
Number of STEMI patients with hospitalizations
Measured: Up to 3 years
Length of hospital stay for STEMI patients
Measured: Up to 3 years
Direct medical costs for STEMI patients
Measured: Up to 3 years
Number of NSTEMI patients with outpatient visits
Measured: Up to 3 years
Number of NSTEMI patients with emergency room visits
Measured: Up to 3 years
Number of NSTEMI patients with hospitalizations
Measured: Up to 3 years
Length of hospital stay for NSTEMI patients
Measured: Up to 3 years
Direct medical costs for NSTEMI patients
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start30 Sep 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Retrospective
- Enrolment
- 124,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05974397
- Sponsor's protocol ID
- CLCZ696BTW05
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Trends in Incidence, Healthcare Utilization, and Mortality in Hospitalized Acute Myocardial Infarction Patients in Taiwan
- ClinicalTrials.gov ID
- NCT05974397
- Acronym / sponsor ID
- CLCZ696BTW05
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124,018 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 3 Aug 2023 (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.
This was a retrospective study using the Taiwan's National Health Insurance Research Database (NHIRD). The study employed two study designs for different purposes as follows:
- A cross-sectional analysis was conducted to explore the annual incidence trends.
- A longitudinal cohort study was conducted to assess baseline characteristics, treatment patterns, long-term healthcare utilization, and cause-specific mortality among incident AMI patients.
In each part, the study was conducted for AMI, and separately for ST-segment elevation and non-ST- segment elevation myocardial infarction (STEMI and NSTEMI)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMI | – | –Patients with AMI |
| STEMI | – | –Patients with STEMI |
| NSTEMI | – | –Patients with NSTEMI |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (11 listed)
- Patients aged 20 years and older.
- Patients who had been admitted for AMI, defined as primary or first secondary diagnosis of AMI between 2014 and 2020.
- The diagnosis of AMI/ STEMI/ NSTEMI was identified by the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes and 10th revision (ICD-10-CM) codes.
- Incident cases of AMI hospitalization were defined as no history of AMI-related hospitalization or outpatient visit within 1 year before admission.
- Patients aged 20 years and older.
Key exclusion criteria (1 listed)
- None specified
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
Mean age of patients
Time frame: 12 months
Number of male patients
Time frame: 12 months
Year of patient entry into cohort
Time frame: 12 months
Number of patients with AMI in Taiwan
Time frame: 12 months
Number of patients with STEMI in Taiwan
Time frame: 12 months
Number of patients with NSTEMI in Taiwan
Time frame: 12 months
Number of AMI patients with comorbidities
Time frame: Up to 3 years
Number of patients with treatment for AMI
Time frame: Up to 3 years
Number of STEMI patients with comorbidities
Time frame: Up to 3 years
Number of patients with treatment for STEMI
Time frame: Up to 3 years
Number of NSTEMI patients with comorbidities
Time frame: Up to 3 years
Number of patients with treatment for NSTEMI
Time frame: Up to 3 years
Number of mortalities among AMI patients
Time frame: Up to 3 years
Number of mortalities among STEMI patients
Time frame: Up to 3 years
Number of mortalities among NSTEMI patients
Time frame: Up to 3 years
Number of AMI patients with outpatient visits
Time frame: Up to 3 years
Number of AMI patients with emergency room visits
Time frame: Up to 3 years
Number of AMI patients with hospitalizations
Time frame: Up to 3 years
Length of hospital stay for AMI patients
Time frame: Up to 3 years
Direct medical costs for AMI patients
Time frame: Up to 3 years
Number of STEMI patients with outpatient visits
Time frame: Up to 3 years
Number of STEMI patients with emergency room visits
Time frame: Up to 3 years
Number of STEMI patients with hospitalizations
Time frame: Up to 3 years
Length of hospital stay for STEMI patients
Time frame: Up to 3 years
Direct medical costs for STEMI patients
Time frame: Up to 3 years
Number of NSTEMI patients with outpatient visits
Time frame: Up to 3 years
Number of NSTEMI patients with emergency room visits
Time frame: Up to 3 years
Number of NSTEMI patients with hospitalizations
Time frame: Up to 3 years
Length of hospital stay for NSTEMI patients
Time frame: Up to 3 years
Direct medical costs for NSTEMI patients
Time frame: Up to 3 years
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 3 Aug 2023.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Novartis Pharmaceuticals at 1 site in Taiwan.
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 11 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 3 Aug 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 Taiwan. 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?
Mean age of patients (time frame: 12 months). The study lists 30 primary outcomes in all. 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 3 Aug 2023.