Ventricular ArrythmiaFUTURENCT05965375
Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias
An observational study of Ventricular Arrythmia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The investigation of biomarkers for immune status and metabolic state, as well as host microbiota composition, in patients with ventricular arrhythmias before and after radiofrequency ablation, can provide new insights for specific and personalized treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Arrythmia
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ventricular premature beats, ventricular tachycardia, or ventricular fibrillation detected by regular surface twelve-lead electrocardiogram or Holter.
Who may be able to join
- Patients with ventricular premature beats, ventricular tachycardia, or ventricular fibrillation detected by regular surface twelve-lead electrocardiogram or Holter.
Who cannot join
- Age <18 or >80 years old;
- Patients with autoimmune diseases or immune deficiencies, or those who have used immunosuppressive or immune modulating agents in the past 3 months;
- Platelet count <100×10^9/L or functional platelet defects;
- Congenital or acquired coagulation or bleeding disorders;
- Patients with a history of organ transplantation or are preparing to receive organ transplantation;
- Unwilling to sign an informed consent or cooperate with the examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chaofeng Sun contact
China1 site
First Affiliated Hospital of Xian Jiantong University
Xi'an, Shaanxi, 710061
About this study
Official title: Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias (FUTURE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study
The investigation of biomarkers for immune status and metabolic state, as well as host microbiota composition, in patients with ventricular arrhythmias before and after radiofrequency ablation, can provide new insights for specific and personalized treatment. This can help establish early prediction and prognosis models and provide a basis for clinically effective diagnosis and treatment.
Read the detailed description
Abnormal immune and metabolic states can lead to the occurrence of various systemic diseases, including the development of cardiovascular diseases through multiple mechanisms. On the other hand, various diseases can also feedback and regulate the immune and metabolic systems. However, currently there is no research on the impact of immune and metabolic states on ventricular arrhythmia. Exploring the biomarker characteristics and risk stratification of patients with ventricular arrhythmias undergoing radiofrequency ablation before and after the procedure can provide new insights for specific and personalized treatment. It can establish early prediction and prognostic models, providing evidence for clinically effective diagnosis and treatment.
- Conditions
- Ventricular Arrythmia
- Being tested
- Observational; No Interventions were given.
- Keywords
- Ventricular Arrhythmia, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational; No Interventions were given.Other
Observational; No Interventions were given.
| Study group | Role | What they receive |
|---|---|---|
| Occasional premature ventricular contractions group | Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Occasional PVCs refer to PVCs that occur less than 6 times per minute. Receives: Other: Observational; No Interventions were given. | |
| Frequent premature ventricular contractions group | Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Frequent PVCs refer to PVCs that occur more than 6 times per minute. Receives: Other: Observational; No Interventions were given. | |
| Short runs of ventricular tachycardia group | Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Short runs of ventricular tachycardia refer to three or more consecutive PVCs that occur within 30 seconds. Receives: Other: Observational; No Interventions were given. | |
| Sustained ventricular tachycardia group | Sustained ventricular tachycardia (VT) is defined as ventricular arrhythmia that lasts for at least 30 seconds and has a heart rate exceeding 100 bpm, or requires termination before 30 seconds due to hemodynamic instability. Receives: Other: Observational; No Interventions were given. | |
| Ventricular fibrillation group | Ventricular fibrillation refers to the complete disappearance of QRS waves, ST segments, and T waves in the ECG, replaced by different shapes, varying amplitudes, and extremely irregular ventricular fibrillation waves. Receives: Other: Observational; No Interventions were given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence of MACCE
Major adverse cardiovascular and cerebrovascular events, including myocardial infarction, stroke, vessel revascularization and all-cause death. The MACCE will be assessed from the medical records.
Measured: 3,6 months,1,3,5 years after enrollment.
Secondary outcomes (4)
Change in the incidence of myocardial infarction
Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records.
Measured: 3,6 months,1,3,5 years after enrollment.
Change in the incidence of stroke
Stroke diagnosed by clinical doctors will be assessed from the medical records.
Measured: 3,6 months,1,3,5 years after enrollment.
Change in the incidence of vessel revascularization
Vessel revascularization assessed by clinical doctors will be assessed from the medical records.
Measured: 3,6 months,1,3,5 years after enrollment.
Change in the incidence of all-cause death
All-cause death diagnosed by clinical doctors will be assessed from the medical records.
Measured: 3,6 months,1,3,5 years after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start31 Dec 2024 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Other
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 521 Hospital of NORINCO Group, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital, Henan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Guoliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityChaofeng Sun, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965375
- Sponsor's protocol ID
- XJTU1AF2023LSK-171
- Acronym
- FUTURE
- Status last verified
- Apr 2024
- First submitted
- 6 Jul 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification Value of Biomarkers in Patients With Ventricular Arrhythmias (FUTURE): an Investigator-initiated, National, Multicenter, Retrospective-prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT05965375
- Acronym / sponsor ID
- FUTURE / XJTU1AF2023LSK-171
- Conditions
- Ventricular Arrythmia
- Keywords
- Ventricular Arrhythmia, Prognosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- 521 Hospital of NORINCO Group, Shaanxi Provincial People's Hospital, Xiangyang Central Hospital, Henan Provincial People's Hospital
- Study start
- 31 Dec 2024 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 28 Jul 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 investigation of biomarkers for immune status and metabolic state, as well as host microbiota composition, in patients with ventricular arrhythmias before and after radiofrequency ablation, can provide new insights for specific and personalized treatment. This can help establish early prediction and prognosis models and provide a basis for clinically effective diagnosis and treatment.
Detailed description
Abnormal immune and metabolic states can lead to the occurrence of various systemic diseases, including the development of cardiovascular diseases through multiple mechanisms. On the other hand, various diseases can also feedback and regulate the immune and metabolic systems. However, currently there is no research on the impact of immune and metabolic states on ventricular arrhythmia. Exploring the biomarker characteristics and risk stratification of patients with ventricular arrhythmias undergoing radiofrequency ablation before and after the procedure can provide new insights for specific and personalized treatment. It can establish early prediction and prognostic models, providing evidence for clinically effective diagnosis and treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Occasional premature ventricular contractions group | – | Other: Observational; No Interventions were given.Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Occasional PVCs refer to PVCs that occur less than 6 times per minute. |
| Frequent premature ventricular contractions group | – | Other: Observational; No Interventions were given.Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Frequent PVCs refer to PVCs that occur more than 6 times per minute. |
| Short runs of ventricular tachycardia group | – | Other: Observational; No Interventions were given.Premature ventricular contractions (PVCs) occur when an electrical impulse originates from an ectopic focus within the ventricle or the interventricular septum, causing premature depolarization of the ventricle before the impulse from the sinoatrial node has reached the ventricle. Short runs of ventricular tachycardia refer to three or more consecutive PVCs that occur within 30 seconds. |
| Sustained ventricular tachycardia group | – | Other: Observational; No Interventions were given.Sustained ventricular tachycardia (VT) is defined as ventricular arrhythmia that lasts for at least 30 seconds and has a heart rate exceeding 100 bpm, or requires termination before 30 seconds due to hemodynamic instability. |
| Ventricular fibrillation group | – | Other: Observational; No Interventions were given.Ventricular fibrillation refers to the complete disappearance of QRS waves, ST segments, and T waves in the ECG, replaced by different shapes, varying amplitudes, and extremely irregular ventricular fibrillation waves. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ventricular premature beats, ventricular tachycardia, or ventricular fibrillation detected by regular surface twelve-lead electrocardiogram or Holter.
Key inclusion criteria (1 listed)
- Patients with ventricular premature beats, ventricular tachycardia, or ventricular fibrillation detected by regular surface twelve-lead electrocardiogram or Holter.
Key exclusion criteria (6 listed)
- Age <18 or >80 years old;
- Patients with autoimmune diseases or immune deficiencies, or those who have used immunosuppressive or immune modulating agents in the past 3 months;
- Platelet count <100×10^9/L or functional platelet defects;
- Congenital or acquired coagulation or bleeding disorders;
- Patients with a history of organ transplantation or are preparing to receive organ transplantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational; No Interventions were given.Observational; No Interventions were given. | Other | Frequent premature ventricular contractions group, Occasional premature ventricular contractions group, Short runs of ventricular tachycardia group, Sustained ventricular tachycardia group, Ventricular fibrillation group |
Primary outcome
Change in the incidence of MACCE
Time frame: 3,6 months,1,3,5 years after enrollment.
Major adverse cardiovascular and cerebrovascular events, including myocardial infarction, stroke, vessel revascularization and all-cause death. The MACCE will be assessed from the medical records.
4 secondary outcomes
Change in the incidence of myocardial infarction
Time frame: 3,6 months,1,3,5 years after enrollment.
Change in the incidence of stroke
Time frame: 3,6 months,1,3,5 years after enrollment.
Change in the incidence of vessel revascularization
Time frame: 3,6 months,1,3,5 years after enrollment.
Change in the incidence of all-cause death
Time frame: 3,6 months,1,3,5 years after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
Related trials for Ventricular Arrythmia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
Arrhythmias, Cardiac
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.
Chaofeng Sun contact
Guoliang Li principal investigator
First Affiliated Hospital Xi'an Jiaotong University
Chaofeng Sun principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 Ventricular Arrythmia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 1 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: opening soon, as of the sponsor's last update on 4 Apr 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoliang Li (+8613759982523, liguoliang_med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence of MACCE (time frame: 3,6 months,1,3,5 years after enrollment.). 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 4 Apr 2024.