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

NCT ID: NCT06174506

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2026-09-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Pharmacy at Ho Chi Minh City

OTHER

Sponsor Role lead

Responsible Party

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Linh Ha Khanh Duong

Duong Ha Khanh Linh

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Linh HK Duong, Master

Role: PRINCIPAL_INVESTIGATOR

Cho Ray Hospital

Locations

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Cho Ray Hospital

Ho Chi Minh City, None Selected, Vietnam

Site Status RECRUITING

Countries

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Vietnam

Central Contacts

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Linh HK Duong, Master, MD

Role: CONTACT

Phone: + 84 0366698048

Email: [email protected]

Facility Contacts

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Thuc T Nguyen, PhD, MD

Role: primary

Other Identifiers

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806/HDDD-DHYD

Identifier Type: -

Identifier Source: org_study_id