The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers

December 7, 2023 updated by: Linh Ha Khanh Duong, University of Medicine and Pharmacy at Ho Chi Minh City

The goal of this clinical trial is to answer the research question whether hs Troponin I and NT-proBNP have a role in detecting atrial fibrillation in patients with pacemakers.

Objectives of the study:

To survey some risk factors for atrial fibrillation in patients with permanent pacemakers.
To determine the role of hs Troponin I and NT-proBNP in predicting new-onset atrial fibrillation within follow-up time.
To build a model to predict the prognosis of atrial fibrillation based on the detected subclinical markers related to atrial fibrillation and classic cardiovascular risk factors.

Study Overview

Status

Recruiting

Conditions

Atrial Fibrillation

Detailed Description

Information about age, gender, BMI, medical history, tests to evaluate liver function, kidney function, dyslipidemia, results of echocardiography, ECG, and chest X-ray will be collected from medical records and clinical examination.

The hs troponin I and NT-proBNP tests will be performed before the patient has a pacemaker.

The two tests above will be paid by research team. Patients do not have to pay for these tests.

Atrial fibrillation will be determined through ECG, holter ECG and pacemaker data.

Time to follow up patients in the study: According to the patient's follow-up visits after pacemaker placement: 1 month, 3 months, 6 months, then every 6 months.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Linh HK Duong, Master, MD
Phone Number: + 84 0366698048
Email: khanhlinh175@gmail.com

Study Locations

Vietnam
- None Selected
  - Ho Chi Minh City, None Selected, Vietnam, 700000
    - Recruiting
    - Cho Ray Hospital
    - Contact:
      
      Thuc T Nguyen, PhD, MD
      
      Phone Number: +84 02838554137
      
      Email: bvchoray@choray.vn
    - Principal Investigator:
      
      Linh HK Duong, Master, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

Patients will be selected from the Arrhythmia Treatment Department of Cho Ray Hospital during the study period.

Adult patients with indications for pacemaker placement, agree to participate in the study, meet the inclusion criteria and do not have the exclusion criteria will be selected for the study.

Description

Inclusion Criteria:

Patient is an adult (≥ 18 years old or older)
There is indication for permanent pacemaker placement and patient agreement to permanent pacemaker placement
Patient agrees to participate in the study

Exclusion Criteria:

Patients had a diagnosis of atrial fibrillation in their past history or atrial fibrillation is discovered at the time of participating in the study
Severe patients, at risk of death
Pregnant
The patient is indicated for surgery
Patients with eGFR ≤ 30 mL/min/1.73m2
The patient has a serious infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Patients with pacemakers without atrial fibrillation at the beginning or in history Patients with pacemakers without atrial fibrillation at the beginning or in history. Patients are adults over 18 years old.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation Time Frame: through study completion, an average of 2 year	Symptomatic or asymptomatic AF that is documented by surface ECG. The minimum duration of an ECG tracing of AF required to establish the diagnosis of clinical AF is at least 30 seconds, or entire 12-lead ECG.	through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial high-rate episodes (AHRE) Time Frame: through study completion, an average of 2 year	AHRE - events fulfilling programmed or specified criteria for AHRE that are detected by CIEDs with an atrial lead allowing automated continuous monitoring of atrial rhythm and tracings storage. CIED-recorded AHRE need to be visually inspected because some AHRE may be electrical artefacts/false positives.	through study completion, an average of 2 year
Subclinical AF Time Frame: through study completion, an average of 2 year	Subclinical AF includes AHRE confirmed to be AF, AFL, or an AT, or AF episodes detected by insertable cardiac monitor or wearable monitor and confirmed by visually reviewed intracardiac electrograms or ECG-recorded rhythm.	through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Investigators

Principal Investigator: Linh HK Duong, Master, Cho Ray Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)