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To identify the risk factors for development of incident Atrial Fibrillation in Indian patients in the tertiary care settings.

Use of machine learning and statistical inference methods for identification of risk factors associated with the development of incident atrial fibrillation (AF) in Indian patients in the tertiary care settings.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/06/043220
Enrollment
5000
Registered
2022-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter

Interventions

Intervention1: Not Applicable: Not Applicable Control Intervention1: Not Applicable: Not Applicable

Sponsors

Pfizer Ltd India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients must meet all the following inclusion criteria to be eligible for inclusion in the study- 1. All patients: Greater than equal to 45 years of age at index date.2. Criteria for cases. a) Continuous enrolment in the dataset for at least 730 days pre-index date (baseline period, that is between 01 January 2016 â?? 31 December 2017). b) Two ECG-datapoints (preferably one each year) during the baseline period (01 January 2016 â?? 31 December 2017). c) Patients with incident documented AF diagnosis between 01 January 2018, and 31 December 2019 (outcome period). d) A new ambulatory verified or primary or secondary hospital discharge diagnosis of AF (ICD-10 GM I48.0/ I48.1/I48.2/I48.9) in the outcome period. 3. Criteria for controls. a) Continuous enrolment in the dataset from the start of the study period to the end of the study period or the date of death (that is between 01 January 2016 to 31 December 2019). b) Two ECG-datapoints (preferably one each year) during the baseline period (01 January 2016 â??31 December 2017). c) No AF diagnosis recorded within the entire study period (baseline and outcome period).

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will not be included in the study- 1. Patients with AF diagnosis in the 24 months pre-index period. 2. Patients with unknown status of AF during the outcome period (January 2018 â??December 2019). 3. Patients with incomplete EMRs.

Design outcomes

Primary

MeasureTime frame
To identify the risk factors for the development of AF in Indian patients at the tertiary care settingsTimepoint: (01 January 2016 to 31 December 2019)—

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable—

Countries

India

Contacts

Public ContactDr Venugopal Madhusudhana

Sekhmet Technologies Pvt. Ltd

venugopal@thb.co.in7738371973

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026