Atrial FibrillationNCT06174506
The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers
An observational study of Atrial Fibrillation, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 300 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Cho Ray Hospital
Ho Chi Minh City, None Selected, 700000
Thuc T Nguyen, PhD, MD, +84 02838554137, bvchoray@choray.vn
Linh HK Duong, Master, MD
About this study
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:
- To survey some risk factors for atrial fibrillation in patients with permanent pacemakers.
- To determine the role of hs Troponin I and NT-proBNP in predicting new-onset atrial fibrillation within follow-up time.
- 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
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.
Measured: through study completion, an average of 2 year
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.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Dec 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linh Ha Khanh Duong, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Linh HK Duong, Master, Principal investigator, Cho Ray Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174506
- Sponsor's protocol ID
- 806/HDDD-DHYD
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of hs Troponin I and NT-proBNP in Predicting Atrial Fibrillation in Patients With Permanent Pacemakers
- ClinicalTrials.gov ID
- NCT06174506
- Acronym / sponsor ID
- 806/HDDD-DHYD
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To survey some risk factors for atrial fibrillation in patients with permanent pacemakers.
- To determine the role of hs Troponin I and NT-proBNP in predicting new-onset atrial fibrillation within follow-up time.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Atrial fibrillation
Time frame: through study completion, an average of 2 year
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.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linh HK Duong, Master principal investigator
Cho Ray Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linh HK Duong, Master, MD (+ 84 0366698048, khanhlinh175@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.