Atrial Fibrillation (AF)NCT06855550
Postoperative Incidence of Atrial Fibrillation Following Cardiac Surgery
An observational study of Atrial Fibrillation (AF) and Hypomagnesemia, run by Fundación Cardioinfantil Instituto de Cardiología at 1 site in Colombia.
Trial summary
Introduction: Postoperative atrial fibrillation is one of the most frequent complications in cardiac surgery, with an expected incidence of more than 50% following valve surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Hypomagnesemia, Cardiac Surgery
- How many people
- 435 participants
- Where
- 1 siteColombia
- Study dates
- 4 May 2015to 12 Dec 2022
- 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 who underwent cardiac surgery at Fundación Cardioinfantil-Instituto de Cardiología, from May 2015 to May 2016.
Who may be able to join
- Adults in postoperative cardiac surgery
Who cannot join
- Preoperative atrial fibrillation
- Without complete information regarding plasmatic magnesium postoperative measurements
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Fundación Cardioinfantil-Instituto de Cardiología
Bogotá, Bogota D.C., 110131
About this study
Official title: Evaluation of Plasmatic Magnesium Levels and Its Association with Atrial Fibrillation After Cardiac Surgery
Introduction: Postoperative atrial fibrillation is one of the most frequent complications in cardiac surgery, with an expected incidence of more than 50% following valve surgery. Hypomagnesemia is also likely to be observed in the postoperative period, and several studies have suggested that it could be related to the incidence of postoperative atrial fibrillation. In this study, via a prospective design and adjustment for multiple covariates, the investigators will seek to determine whether plasma magnesium levels are independently associated with the appearance of postoperative atrial fibrillation.
Methods: An analytical design involving a concurrent cohort will be carried out in a high-complexity hospital with a cardiovascular focus. Serial postoperative plasma magnesium measurements will be included as independent variables in a logistic regression model to determine their association with atrial fibrillation after adjusting for multiple covariates.
- Conditions
- Atrial Fibrillation (AF), Hypomagnesemia, Cardiac Surgery
- 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 |
|---|---|---|
| Postoperative cardiac surgery | Patients who will undergo elective cardiac surgery of any kind will be included, except those with a history of preoperative atrial fibrillation, urgent/emergency surgery, or those who will undergo maze surgery (alone or in combination with other procedures). Magnesium levels will be measured immediately after surgery and every subsequent 12-24 hours during the stay in the intensive care unit. Each patient will be followed up, and morbidity and mortality will be recorded through in-hospital evaluation or up to 30 days postoperatively (whichever occurs first). Follow-up will be performed by a member of the research team who will be blinded to the postoperative magnesium levels. Preoperative evaluation, premedication, anesthetic/surgical technique, and postoperative care will conducted according to institutional protocols; no modifications of any kind will be made for the participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Atrial fibrilation
Defined as irregular QRS without p wave during 30 seconds in a 12 derivations EKG.
Measured: Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)
Secondary outcomes (1)
Mortality
Overall mortality rate.
Measured: Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start4 May 2015
- Primary completion3 Jun 2016
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Cardioinfantil Instituto de Cardiología
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edgar Hernández Leiva, Fundación Cardioinfantil Instituto de Cardiología
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855550
- Sponsor's protocol ID
- 2023PROCCA0043
- Other IDs
- 2023PROCCA0043
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data from the study would be provided by request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Plasmatic Magnesium Levels and Its Association with Atrial Fibrillation After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06855550
- Acronym / sponsor ID
- 2023PROCCA0043
- Conditions
- Atrial Fibrillation (AF), Hypomagnesemia, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Fundación Cardioinfantil Instituto de CardiologíaUniversity, hospital or other
- Study start
- 4 May 2015 (actual)
- Primary completion
- 3 Jun 2016 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 4 Mar 2025 (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.
Introduction: Postoperative atrial fibrillation is one of the most frequent complications in cardiac surgery, with an expected incidence of more than 50% following valve surgery. Hypomagnesemia is also likely to be observed in the postoperative period, and several studies have suggested that it could be related to the incidence of postoperative atrial fibrillation. In this study, via a prospective design and adjustment for multiple covariates, the investigators will seek to determine whether plasma magnesium levels are independently associated with the appearance of postoperative atrial fibrillation.
Methods: An analytical design involving a concurrent cohort will be carried out in a high-complexity hospital with a cardiovascular focus. Serial postoperative plasma magnesium measurements will be included as independent variables in a logistic regression model to determine their association with atrial fibrillation after adjusting for multiple covariates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative cardiac surgery | – | –Patients who will undergo elective cardiac surgery of any kind will be included, except those with a history of preoperative atrial fibrillation, urgent/emergency surgery, or those who will undergo maze surgery (alone or in combination with other procedures). Magnesium levels will be measured immediately after surgery and every subsequent 12-24 hours during the stay in the intensive care unit. Each patient will be followed up, and morbidity and mortality will be recorded through in-hospital evaluation or up to 30 days postoperatively (whichever occurs first). Follow-up will be performed by a member of the research team who will be blinded to the postoperative magnesium levels. Preoperative evaluation, premedication, anesthetic/surgical technique, and postoperative care will conducted according to institutional protocols; no modifications of any kind will be made for the participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent cardiac surgery at Fundación Cardioinfantil-Instituto de Cardiología, from May 2015 to May 2016.
Key inclusion criteria (1 listed)
- Adults in postoperative cardiac surgery
Key exclusion criteria (2 listed)
- Preoperative atrial fibrillation
- Without complete information regarding plasmatic magnesium postoperative measurements
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
Postoperative Atrial fibrilation
Time frame: Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)
Defined as irregular QRS without p wave during 30 seconds in a 12 derivations EKG.
1 secondary outcome
Mortality
Time frame: Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: Undecided. Data from the study would be provided by request to the principal investigator.
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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (AF) and Hypomagnesemia, run by Fundación Cardioinfantil Instituto de Cardiología at 1 site in Colombia.
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 2 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: finished, as of the sponsor's last update on 7 Mar 2025. 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 Colombia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Atrial fibrilation (time frame: Measurement was performed first day after surgery up to 30 days postoperatively or discharge (whichever came first)). 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 7 Mar 2025.