Atrial FibrillationPhase 3NCT06378021
Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG
A Phase 3 study testing Calcium Chloride and Sodium Chloride 0.9% Inj in people with Atrial Fibrillation, run by Helwan University at 1 site in Egypt.
Trial summary
This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Calcium Chloride and Sodium Chloride 0.9% Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Mar 2024to Apr 2025
- Phase
- Phase 3
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Patients more than 18 years old 2 ) patients undergoing On pump CABG
Who cannot join
- patients >75 years of age
- Patients with Pre operative Atrial fibrillation
- Patients with Significant valvular disease
- 5. Ejection fraction <30% 6. Combined surgery of any kind 7. Congenital heart disease 8. Abnormal severe liver or kidney dysfunction. 9. Patients undergoing Off-pump CABG 10. Poorly controlled hyperthyroidism 11. Refusal to enrollment.
Trial locations and contacts
1 site in 1 country.
Ahmed A Foad, Assoc prof contact
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university
Cairo, Abassia Cairo, 02
Mohamed A Gamal, Ass prof, 010080827060 ext. 02
Abdelhameed I Ebid, Prof
About this study
Official title: Post Operative Atrial Fibrillation: Alleviation by Calcium Chloride Injection Into Cardiac Ganglionic Plexus During Coronary Artery Bypass Grafting.
This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient.
The intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation
Read the detailed description
This study hypothesize that injecting calcium chloride into the major atrial ganglionic plexus (GPs) during On pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation by calcium-induced autonomic neurotoxicity, the incidence of Post operative Atrial fibrillation can be reduced by suppressing the function of the major atrial GPs and the surrounding neural network that play an important role in initiating Post operative Atrial fibrillation. The study is designed to be prospective interventional study two armed RCT for on pump CABG patient. The plan of work will include dividing the patients into 2 randomized control groups In the intervention group patients will be injected with 5% Calcium chloride in the 4 Major atrial ganglionic plexus The other arm will be Coronary artery bypass graft patients who will be injected with sodium chloride 0.9% to compare the two groups to evaluate to evaluate the effect of Calcium chloride in post CABG atrial fibrillation between the 2 arms of the study.
- Conditions
- Atrial Fibrillation
- Being tested
- Calcium Chloride, Sodium Chloride 0.9% Inj
- Keywords
- Atrial fibrillation, Calcium chloride, On pump Coronary artery bypass graft
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium ChlorideDrug
Also called 10% ampoules calcium chloride
5 % calcium chloride injection in cardiac ganglionic Plexus during On pump Coronary artery bypass graft
Sodium Chloride 0.9% InjDrug
Also called Normal saline
0.9% sodium chloride injection during on pump during Coronary artery bypass graft
| Study group | Role | What they receive |
|---|---|---|
| Calcium chloride injection in ganglionated plexis for Atrial Fibrillation alleviation post CABG | Experimental | The Patients in the intervention arm will be injected with Calcium chloride in the 4 major atrial ganglionated plexis after the by pass is completed. Receives: Drug: Calcium Chloride |
| patients who will receive their regular standard of care without calcium chloride injection | Placebo comparator | A group of patients who will undergo Coronary artery bypass graft surgery will be injected with normal saline in the ganglionic Plexus during Coronary artery bypass graft to act as a comparator to determine if calcium chloride injection alleviate Atrial fibrillation post surgery Receives: Drug: Sodium Chloride 0.9% Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of patients who developed Atrial fibrillation
Compare if calcium chloride injection decrease the percentage of patients who developed Atrial fibrillation in intervention group with those in placebo group
Measured: Up to one week from the time of surgery determined by serial ECGs per day
Secondary outcomes (1)
Change in length of hospital stay
investigate if calcium chloride will decrease duration of hospital stay compared with those in the placebo group who are injected with normal saline
Measured: Up to the time of patient discharge from the hospital (from the time of post Coronary artery bypass graft surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start14 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Osama Elgarhi, Helwan University
- Investigators
- Abdelhameed I Ebid, Principal investigator, Prof
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378021
- Sponsor's protocol ID
- Calcium chloride in CABG
- Status last verified
- Apr 2024
- First submitted
- 22 Mar 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang H, Zhang Y, Xin F, Jiang H, Tao D, Jin Y, He Y, Wang Q, Po SS. Calcium-Induced Autonomic Denervation in Patients With Post-Operative Atrial Fibrillation. J Am Coll Cardiol. 2021 Jan 5;77(1):57-67. doi: 10.1016/j.jacc.2020.10.049.
PubMed 33413942
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Operative Atrial Fibrillation: Alleviation by Calcium Chloride Injection Into Cardiac Ganglionic Plexus During Coronary Artery Bypass Grafting.
- ClinicalTrials.gov ID
- NCT06378021
- Acronym / sponsor ID
- Calcium chloride in CABG
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Calcium chloride, On pump Coronary artery bypass graft
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 22 Apr 2024 (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.
This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient.
The intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation
Detailed description
This study hypothesize that injecting calcium chloride into the major atrial ganglionic plexus (GPs) during On pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation by calcium-induced autonomic neurotoxicity, the incidence of Post operative Atrial fibrillation can be reduced by suppressing the function of the major atrial GPs and the surrounding neural network that play an important role in initiating Post operative Atrial fibrillation. The study is designed to be prospective interventional study two armed RCT for on pump CABG patient. The plan of work will include dividing the patients into 2 randomized control groups In the intervention group patients will be injected with 5% Calcium chloride in the 4 Major atrial ganglionic plexus The other arm will be Coronary artery bypass graft patients who will be injected with sodium chloride 0.9% to compare the two groups to evaluate to evaluate the effect of Calcium chloride in post CABG atrial fibrillation between the 2 arms of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium chloride injection in ganglionated plexis for Atrial Fibrillation alleviation post CABG | Experimental | Drug: Calcium ChlorideThe Patients in the intervention arm will be injected with Calcium chloride in the 4 major atrial ganglionated plexis after the by pass is completed. |
| patients who will receive their regular standard of care without calcium chloride injection | Placebo comparator | Drug: Sodium Chloride 0.9% InjA group of patients who will undergo Coronary artery bypass graft surgery will be injected with normal saline in the ganglionic Plexus during Coronary artery bypass graft to act as a comparator to determine if calcium chloride injection alleviate Atrial fibrillation post surgery |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Patients more than 18 years old 2 ) patients undergoing On pump CABG
Key exclusion criteria (4 listed)
- patients >75 years of age
- Patients with Pre operative Atrial fibrillation
- Patients with Significant valvular disease
- 5. Ejection fraction <30% 6. Combined surgery of any kind 7. Congenital heart disease 8. Abnormal severe liver or kidney dysfunction. 9. Patients undergoing Off-pump CABG 10. Poorly controlled hyperthyroidism 11. Refusal to enrollment.
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 |
|---|---|---|
| Calcium ChlorideAlso: 10% ampoules calcium chloride5 % calcium chloride injection in cardiac ganglionic Plexus during On pump Coronary artery bypass graft | Drug | Calcium chloride injection in ganglionated plexis for Atrial Fibrillation alleviation post CABG |
| Sodium Chloride 0.9% InjAlso: Normal saline0.9% sodium chloride injection during on pump during Coronary artery bypass graft | Drug | patients who will receive their regular standard of care without calcium chloride injection |
Primary outcome
Change in number of patients who developed Atrial fibrillation
Time frame: Up to one week from the time of surgery determined by serial ECGs per day
Compare if calcium chloride injection decrease the percentage of patients who developed Atrial fibrillation in intervention group with those in placebo group
1 secondary outcome
Change in length of hospital stay
Time frame: Up to the time of patient discharge from the hospital (from the time of post Coronary artery bypass graft surgery)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 33413942Wang H, Zhang Y, Xin F, Jiang H, Tao D, Jin Y, He Y, Wang Q, Po SS. Calcium-Induced Autonomic Denervation in Patients With Post-Operative Atrial Fibrillation. J Am Coll Cardiol. 2021 Jan 5;77(1):57-67. doi: 10.1016/j.jacc.2020.10.049.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Ahmed A Foad, Assoc prof contact
Abdelhameed I Ebid principal investigator
Prof
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcium Chloride and Sodium Chloride 0.9% Inj in people with Atrial Fibrillation, run by Helwan University at 1 site in Egypt.
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 4 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 22 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nadine O Elgarhi, pharmacist (01144249948 ext. 02, nadinesadek2013@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of patients who developed Atrial fibrillation (time frame: Up to one week from the time of surgery determined by serial ECGs per day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06378021, which also lists 1 linked publication.
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 22 Apr 2024.