NCT05974397

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124,018

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

10 months

First QC Date

July 20, 2023

Last Update Submit

August 1, 2023

Conditions

Outcome Measures

Primary Outcomes (30)

  • Mean age of patients

    12 months

  • Number of male patients

    12 months

  • Year of patient entry into cohort

    12 months

  • Number of patients with AMI in Taiwan

    12 months

  • Number of patients with STEMI in Taiwan

    12 months

  • Number of patients with NSTEMI in Taiwan

    12 months

  • Number of AMI patients with comorbidities

    Up to 3 years

  • Number of patients with treatment for AMI

    Up to 3 years

  • Number of STEMI patients with comorbidities

    Up to 3 years

  • Number of patients with treatment for STEMI

    Up to 3 years

  • Number of NSTEMI patients with comorbidities

    Up to 3 years

  • Number of patients with treatment for NSTEMI

    Up to 3 years

  • Number of mortalities among AMI patients

    Up to 3 years

  • Number of mortalities among STEMI patients

    Up to 3 years

  • Number of mortalities among NSTEMI patients

    Up to 3 years

  • Number of AMI patients with outpatient visits

    Up to 3 years

  • Number of AMI patients with emergency room visits

    Up to 3 years

  • Number of AMI patients with hospitalizations

    Up to 3 years

  • Length of hospital stay for AMI patients

    Up to 3 years

  • Direct medical costs for AMI patients

    Up to 3 years

  • Number of STEMI patients with outpatient visits

    Up to 3 years

  • Number of STEMI patients with emergency room visits

    Up to 3 years

  • Number of STEMI patients with hospitalizations

    Up to 3 years

  • Length of hospital stay for STEMI patients

    Up to 3 years

  • Direct medical costs for STEMI patients

    Up to 3 years

  • Number of NSTEMI patients with outpatient visits

    Up to 3 years

  • Number of NSTEMI patients with emergency room visits

    Up to 3 years

  • Number of NSTEMI patients with hospitalizations

    Up to 3 years

  • Length of hospital stay for NSTEMI patients

    Up to 3 years

  • Direct medical costs for NSTEMI patients

    Up to 3 years

Study Arms (3)

AMI

Patients with AMI

STEMI

Patients with STEMI

NSTEMI

Patients with NSTEMI

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

  • 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.

You may not qualify if:

  • None specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Taipei, Taiwan

Location

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 3, 2023

Study Start

September 30, 2021

Primary Completion

July 22, 2022

Study Completion

July 22, 2022

Last Updated

August 3, 2023

Record last verified: 2023-07

Locations