Calcitonin Secretion DisorderNCT04993456
Calcitonin Level and New-onset of Post-Operative Atrial Fibrillation
An observational study of Calcitonin Secretion Disorder and Post-operative Atrial Fibrillation, run by Tongji Hospital at 1 site in China.
Trial summary
Post-operative atrial fibrillation (POAF) is one of the common complicaiton following cardiac surgery, occurring in approximately 20%-40% patients. Although POAF is associated with longer hospital stays, most POAF is short lived and resolves in the 2-4 days afer cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Calcitonin Secretion Disorder, Post-operative Atrial Fibrillation
- What is being tested?
- Caridac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2021to 15 Jul 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is expected that 200 patients who received the first non-emergency cardiopulmonary bypass cardiac surgery in our hospital will be enrolled.
Who may be able to join
- 1. Clinical diagnosis of no history of atrial fibrillation/flutter;
- 2. Heart rate ≥50 beats/min;
- 3. EF > 40%;
- 4. No history of emergency cardiac surgery in our hospital;
- 5. Participate voluntarily and sign the informed consent, and can accept the follow-up of more than 2 years.
Who cannot join
- 1. Atrial fibrillation/flutter;
- 2. Left atrial diameter >5.5cm;
- 3. Previous cardiac surgery or emergency surgery (<12h);
- 4. Sick sinus node syndrome;
- 5. Ventricular preexcitation or preexcitation syndrome;
- 6. Second degree or above atrioventricular block;
Show all 16Show fewer
- 7.Myocardial infarction occurred within 7 days;
- 8. Infection, sepsis, rheumatic or inflammatory diseases;
- 9. Abnormal liver and kidney function (three times higher than the upper limit of normal);
- 10. Uncontrolled hyperthyroidism, severe obstructive sleep apnea, and acute alcoholism;
- 11. Any ischemic events (stroke or TIA) that occurred 180 days before the participant signed the informed consent, or any known unresolved complications from previous stroke/TIA;Thrombosis;
- 12. Patients with other diseases requiring radiotherapy, chemotherapy and long-term hormone therapy;
- 13. Patients' life expectancy makes it unlikely that follow-up will be completed;
- 14. Participate in, or are expected to participate in, other clinical trials of any drugs, devices or biologics during the study period;
- 15. Patients with contraindications to dynamic electrocardiogram;
- 16. Patients who are unwilling or unable to fully comply with study procedures and follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Li Ni, PHD, +862783662479, nili@tjh.tjmu.edu.cn
About this study
Official title: Division of Cardiology, Department of Internal Medicne, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
Post-operative atrial fibrillation (POAF) is one of the common complicaiton following cardiac surgery, occurring in approximately 20%-40% patients. Although POAF is associated with longer hospital stays, most POAF is short lived and resolves in the 2-4 days afer cardiac surgery.
However, a recent meta-analysis showed significant increases in 1,5, and 10 year mortality in POAF patients (odds ratio:1.60, 2.60, 1.51;95% confidence intervals: 1.52 to 1.68, 2.00 to 3.38, 1.43 to 1.60;P <0.0001), the combined adjusted risk of death (16 studies, n =84,295) was also significantly increased in patients with POAF (hazard ratio: 1.25;95% confidence interval: 1.2-1.3;P < 0.0001).
Read more
These data highlight the need to understand better the underlying mechanism of POAF. A latest research in Nature reported levels of circulating calcitonin (CT), which is the main risk factor for atrial fibrillation (AF). Global disruption of CT receptor signalling in mice causes atrial fibrosis and increases susceptibility to AF.
Here we will explore the relationship between CT and POAF.
- Being tested
- Caridac surgery
- Keywords
- Post-operative atrial fibrillation, Calcitonin, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caridac surgeryProcedure or surgery
Cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| POAF group | the patients will have atrial fibrillation following the cardiac surgery Receives: Procedure: Caridac surgery | |
| non-POAF group | the patients will have no atrial fibrillation following the cardiac surgery Receives: Procedure: Caridac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
POAF lasting longer than 30 seconds during the first week after cardiac surgery
The incidence of atrial fibrillation lasting longer than 30 seconds during the first week after cardiac surgery
Measured: 2 years after cardiac surgery
Secondary outcomes (7)
The hospitalization days
The length of stay after the cardiac surgery
Measured: 2 years after cardiac surgery
Ventricular rate of the atrial fibrillation
Ventricular rate of atrial fibrillation after the cardiac surgery
Measured: 2 years after cardiac surgery
Levels of serum calcitonin
Levels of serum calcitonin of atrial fibrillation after the cardiac surgery
Measured: 2 years after cardiac surgery
Levels of serum procalcitonin
Levels of serum procalcitonin of atrial fibrillation after the cardiac surgery
Measured: 2 years after cardiac surgery
Levels of serum hsCRP
Levels of serum hsCRP of atrial fibrillation after the cardiac surgery
Measured: 2 years after cardiac surgery
Levels of serum cytokines(IL-1β，IL-2R，IL-6，IL-8，IL-10，TNF-α)
Levels of serum cytokines(IL-1β，IL-2R，IL-6，IL-8，IL-10，TNF-α) of atrial fibrillation after the cardiac surgery
Measured: 2 years after cardiac surgery
Atrial fibrillation burden after cardiac surgery
Time and length of atrial fibrillation after cardiac surgery
Measured: lidan2014@tjh.tjmu.edu.cn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start15 Jun 2021
- Primary completion15 Jul 2023 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcitonin Secretion DisorderStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Ni, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993456
- Sponsor's protocol ID
- TJ-CT-POAF
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Division of Cardiology, Department of Internal Medicne, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
- ClinicalTrials.gov ID
- NCT04993456
- Acronym / sponsor ID
- TJ-CT-POAF
- Keywords
- Post-operative atrial fibrillation, Calcitonin, Cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 6 Aug 2021 (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.
Post-operative atrial fibrillation (POAF) is one of the common complicaiton following cardiac surgery, occurring in approximately 20%-40% patients. Although POAF is associated with longer hospital stays, most POAF is short lived and resolves in the 2-4 days afer cardiac surgery.
However, a recent meta-analysis showed significant increases in 1,5, and 10 year mortality in POAF patients (odds ratio:1.60, 2.60, 1.51;95% confidence intervals: 1.52 to 1.68, 2.00 to 3.38, 1.43 to 1.60;P <0.0001), the combined adjusted risk of death (16 studies, n =84,295) was also significantly increased in patients with POAF (hazard ratio: 1.25;95% confidence interval: 1.2-1.3;P < 0.0001).
These data highlight the need to understand better the underlying mechanism of POAF. A latest research in Nature reported levels of circulating calcitonin (CT), which is the main risk factor for atrial fibrillation (AF). Global disruption of CT receptor signalling in mice causes atrial fibrosis and increases susceptibility to AF.
Here we will explore the relationship between CT and POAF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAF group | – | Procedure: Caridac surgerythe patients will have atrial fibrillation following the cardiac surgery |
| non-POAF group | – | Procedure: Caridac surgerythe patients will have no atrial fibrillation following the cardiac surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is expected that 200 patients who received the first non-emergency cardiopulmonary bypass cardiac surgery in our hospital will be enrolled.
Key inclusion criteria (5 listed)
- 1. Clinical diagnosis of no history of atrial fibrillation/flutter;
- 2. Heart rate ≥50 beats/min;
- 3. EF > 40%;
- 4. No history of emergency cardiac surgery in our hospital;
- 5. Participate voluntarily and sign the informed consent, and can accept the follow-up of more than 2 years.
Key exclusion criteria (16 listed)
- 1. Atrial fibrillation/flutter;
- 2. Left atrial diameter >5.5cm;
- 3. Previous cardiac surgery or emergency surgery (<12h);
- 4. Sick sinus node syndrome;
- 5. Ventricular preexcitation or preexcitation syndrome;
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 |
|---|---|---|
| Caridac surgeryCardiac surgery | Procedure or surgery | POAF group, non-POAF group |
Primary outcome
POAF lasting longer than 30 seconds during the first week after cardiac surgery
Time frame: 2 years after cardiac surgery
The incidence of atrial fibrillation lasting longer than 30 seconds during the first week after cardiac surgery
7 secondary outcomes
The hospitalization days
Time frame: 2 years after cardiac surgery
Ventricular rate of the atrial fibrillation
Time frame: 2 years after cardiac surgery
Levels of serum calcitonin
Time frame: 2 years after cardiac surgery
Levels of serum procalcitonin
Time frame: 2 years after cardiac surgery
Levels of serum hsCRP
Time frame: 2 years after cardiac surgery
Levels of serum cytokines(IL-1β，IL-2R，IL-6，IL-8，IL-10，TNF-α)
Time frame: 2 years after cardiac surgery
Atrial fibrillation burden after cardiac surgery
Time frame: lidan2014@tjh.tjmu.edu.cn
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: Undecided
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.
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 Calcitonin Secretion Disorder and Post-operative Atrial Fibrillation, run by Tongji Hospital 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 5 inclusion and 16 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 17 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POAF lasting longer than 30 seconds during the first week after cardiac surgery (time frame: 2 years after cardiac surgery). 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 17 Aug 2021.