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

NCT06174506 | Recruiting

• 1 other identifier: 806/HDDD-DHYD
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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. 1.To survey some risk factors for atrial fibrillation in patients with permanent pacemakers.
2. 2.To determine the role of hs Troponin I and NT-proBNP in predicting new-onset atrial fibrillation within follow-up time.
3. 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Atrial high-rate episodes (AHRE)

  through study completion, an average of 2 year

• Subclinical AF

  through study completion, an average of 2 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Cho Ray Hospital

Ho Chi Minh City, None Selected, 700000, Vietnam

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples will be drawn from fasting participants. The blood then will be promptly processed, and serum or plasma will be used for quantification of hs Troponin I or NT-proBNP.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Linh HK Duong, Master

  Cho Ray Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linh HK Duong, Master, MD

CONTACT

+ 84 0366698048; khanhlinh175@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Duong Ha Khanh Linh

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 18, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)