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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174506
• Other study ID #: 806/HDDD-DHYD
• Status: Recruiting
• Start date: December 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: December 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: Linh HK Duong, Master, MD
• Phone: + 84 0366698048
• Email: khanhlinh175[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Vietnam	Cho Ray Hospital	Ho Chi Minh City	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation	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	Atrial high-rate episodes (AHRE)	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
Secondary	Subclinical AF	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