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NCT04090918
Novel Methods for Characterizing Patients With Post-operative Atrial Fibrillation Secondary to Abdominal Surgery
trial testing Cardiac examination programme 3 months after abdominal surgery in Atrial Fibrillation. Withdrawn.
19 October 2021
Quick facts
| Lead sponsor | Frederiksberg University Hospital |
|---|---|
| Status | Withdrawn |
| Study type | OBSERVATIONAL |
| Start date | 19 October 2021 |
| Primary completion | 19 October 2021 |
| Estimated completion | 19 October 2021 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Cardiac examination programme 3 months after abdominal surgery
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
- Surgery--Complications — all drugs for Surgery--Complications →
Sponsor
Frederiksberg University Hospital
Who can join
18 and older, any sex, with Atrial Fibrillation or Surgery--Complications. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Purpose The primary purpose of the current project is to characterize unselected patients undergoing surgery developing post-operative atrial fibrillation (POAF), ultimately leading to a new risk-stratification model. Background and rationale According to rather scarce existing reports, it is estimated that 10% will develop POAF following abdominal surgery. It remains a challenge for the clinicians to predict which patients are at risk. POAF can be difficult to diagnose, as symptoms are often vague. Hence, the diagnosis may remain underreported leaving many patients without adequate treatment. Untreated atrial fibrillation is associated with increased morbidity and mortality, especially due to an increased risk of ischemic stroke. Methods Three-hundred adult patients admitted for surgery at the Digestive Disease Center at Bispebjerg Hospital will be examined by heart rhythm monitoring during hospitalization, i.e. pre-, peri- and postoperatively in the main SECAFIB-SURG study. Twenty study participants who develop POAF and 20 without POAF matched with these on sex, age and co-morbidity, will undergo additional cardiovascular examinations three months after surgery in the current sub-study. All patients will be followed for at least one year after surgery. The study is scheduled for completion within two years, commencing in January 2020. Perspective Creating a POAF risk-stratification model for patients undergoing abdominal surgery, could ensure timely diagnosis and treatment, hence, preventing complications associated with POAF.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04090918 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Frederiksberg University Hospital
- Last refreshed: 27 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04090918.
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