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

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT06174506
• Lead Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Brief Summary

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:

1. To survey some risk factors for atrial fibrillation in patients with permanent pacemakers.

2. To determine the role of hs Troponin I and NT-proBNP in predicting new-onset atrial fibrillation within follow-up time.

3. 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.

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 Timeline

• Study First Submitted: 2023-11-30
• Status Verified: 2023-12
• Study Start: 2023-12-01
• Study First Submitted QC: 2023-12-07
• Last Update Submitted: 2023-12-07
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	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.

Secondary Outcome Measures

Name	Time	Method
Subclinical AF	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.
Atrial high-rate episodes (AHRE)	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.

Trial Locations

Locations (1)

Cho Ray Hospital; 🇻🇳 Ho Chi Minh City, None Selected, Vietnam