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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05974397
Other study ID # CLCZ696BTW05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 30, 2021
Est. completion date July 22, 2022

Study information

Verified date July 2023
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. - 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)


Recruitment information / eligibility

Status Completed
Enrollment 124018
Est. completion date July 22, 2022
Est. primary completion date July 22, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 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: 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. Exclusion Criteria: None specified

Study Design


Locations

Country Name City State
Taiwan Novartis Taipei

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean age of patients 12 months
Primary Number of male patients 12 months
Primary Year of patient entry into cohort 12 months
Primary Number of patients with AMI in Taiwan 12 months
Primary Number of patients with STEMI in Taiwan 12 months
Primary Number of patients with NSTEMI in Taiwan 12 months
Primary Number of AMI patients with comorbidities Up to 3 years
Primary Number of patients with treatment for AMI Up to 3 years
Primary Number of STEMI patients with comorbidities Up to 3 years
Primary Number of patients with treatment for STEMI Up to 3 years
Primary Number of NSTEMI patients with comorbidities Up to 3 years
Primary Number of patients with treatment for NSTEMI Up to 3 years
Primary Number of mortalities among AMI patients Up to 3 years
Primary Number of mortalities among STEMI patients Up to 3 years
Primary Number of mortalities among NSTEMI patients Up to 3 years
Primary Number of AMI patients with outpatient visits Up to 3 years
Primary Number of AMI patients with emergency room visits Up to 3 years
Primary Number of AMI patients with hospitalizations Up to 3 years
Primary Length of hospital stay for AMI patients Up to 3 years
Primary Direct medical costs for AMI patients Up to 3 years
Primary Number of STEMI patients with outpatient visits Up to 3 years
Primary Number of STEMI patients with emergency room visits Up to 3 years
Primary Number of STEMI patients with hospitalizations Up to 3 years
Primary Length of hospital stay for STEMI patients Up to 3 years
Primary Direct medical costs for STEMI patients Up to 3 years
Primary Number of NSTEMI patients with outpatient visits Up to 3 years
Primary Number of NSTEMI patients with emergency room visits Up to 3 years
Primary Number of NSTEMI patients with hospitalizations Up to 3 years
Primary Length of hospital stay for NSTEMI patients Up to 3 years
Primary Direct medical costs for NSTEMI patients Up to 3 years
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