Identifying stroke risk in heart surgery patients
Left Atrial Appendage Arrhythmogenic and Thrombogenic Substrate
This study is trying to see if looking at heart scans can help find patients at risk of strokes before they have heart surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Bispebjerg and Frederiksberg Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06405750 on ClinicalTrials.gov |
What this trial studies
This project aims to determine if patients at risk of forming blood clots, which can lead to strokes, can be identified through electrocardiogram analysis. Patients scheduled for elective heart surgery will have their left atrial appendage closed, a common procedure for those with atrial fibrillation. During surgery, tissue from the appendage will be collected for analysis alongside blood samples and ECG data. The study will investigate thrombosis factors and inflammatory markers to better understand the arrhythmogenic and thrombogenic substrates.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective open-heart surgeries such as CABG, valve repair or replacement, or aorta surgery.
Not a fit: Patients with current endocarditis or those for whom follow-up is not possible may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification of patients at risk for stroke, allowing for better preventative measures.
How similar studies have performed: Other studies have shown promise in identifying stroke risk through similar methodologies, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Helena DOMINGUEZ, MD, PhD
- Email: mdom0002@regionh.dk
- Phone: 4522989343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.