Clinical trial NCT06174506: The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers
Official title: The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Atrial fibrillation
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Atrial high-rate episodes (AHRE)
timeFrame: through study completion, an average of 2 year
measure: Subclinical AF
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Cho Ray Hospital
state: None Selected
Study officials:
affiliation: Cho Ray Hospital
name: Linh HK Duong, Master
role: PRINCIPAL_INVESTIGATOR
References: