Clinical trial NCT06405750: Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
Official title: Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Keywords: heart surgery
atrial myocardiopathy
arrhythmogenic substrate
stroke
cerebral transitory ischemic attack
thrombogenesis
cardiac embolism
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: University of Copenhagen
First posted: 2024-05-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mechanistic study based on analysis of biological material collected along with electrocardiogram features on individuals undergoing open-heart surgery
Primary purpose: OTHER

Brief summary: The purpose of the project is to elucidate whether it is possible to identify which patients are at risk of forming blood clots that can cause stroke based on analysis of the electrocardiogram.

In connection with the operation, the small pouch known as the auricle of the heart is closed, which can be completely removed after closing. This procedure is common in patients with atrial fibrillation to protect the brain from stroke. In the project, all patients will have this auricle closed if they agree to participate in the project.

After closure, the auricle is usually discarded. We will analyze the blood and the auricle tissue taken (if available) in connection with the operation itself, together with the analysis of the electrocardiogram recorded before the planned heart operation.

Detailed description: Patients scheduled for elective heart surgery are invited to participate. After informed consent is signed, an ECG and blood samples are gathered the day before surgery or the same day of the surgery is planned.

During surgery, the patients undergo closure of the left atrial appendage (LAA). The choice of the device is at the discretion of the surgeon. If possible, the entire LAA is removed and processed for further analysis. The right atrial appendage is likewise removed and follows the same procedure as the LAA.

The analyses include measurement of up-/down-regulated thrombosis factors and inflammatory markers.

The right and left atrial appendage tissue collected are immediately processed for micro-patch-clamp studies, and the remaining tissue is divided into a part that is frozen for later analyses and a part that is fixed and embedded in paraffin for further histological analyses.

Eligibility criteria: Inclusion Criteria:

* signed informed consent AND
* planned any open-heart surgery:

  * CABG
  * valve repair or replacement
  * aorta surgery
  * any combination of the above

Exclusion Criteria:

* current endocarditis
* follow-up not possible

Primary outcomes:
measure: stroke
timeFrame: six years
Secondary outcomes:
measure: perioperative atrial fibrillation
timeFrame: 30 days
measure: silent brain infarctions
timeFrame: six years
measure: occurrence of atrial fibrillation during follow-up
timeFrame: ten years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: University Hospital Bispebjerg and Frederiksberg
name: Helena Dominguez
role: STUDY_DIRECTOR
References: