The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Atrial fibrillation [Time frame: through study completion, an average of 2 year]
Secondary outcome measures (2)
- Atrial high-rate episodes (AHRE) [Time frame: through study completion, an average of 2 year]
- Subclinical AF [Time frame: through study completion, an average of 2 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Vietnam · 1 center
- Cho Ray Hospital — Ho Chi Minh City
Identifiers
NCT: NCT06174506 · 806/HDDD-DHYD