Investigating swallowing difficulties after heart imaging in stroke patients
Transoesophageal Echocardiography - Dysphagia Risk in Acute Stroke- TEDRAS 2 - Follow Up
This study is trying to see if heart imaging can lead to swallowing problems in stroke patients and how severe those issues might be.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Giessen Academic / other |
| Locations | 1 site (Giessen, Hesse) |
| Trial ID | NCT06195501 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to follow up on the initial TEDRAS-Trial, which assessed the risk of dysphagia in patients who underwent transesophageal echocardiography (TEE) after experiencing an acute ischemic stroke. The study will evaluate the limitations of the previous trial and further investigate the correlation between TEE and the severity of swallowing difficulties. Patients will undergo clinical swallowing screenings and flexible endoscopic evaluations to assess dysphagia symptoms using standardized scoring systems. The goal is to enhance early detection and management of dysphagia to improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with acute ischemic stroke who require transesophageal echocardiography and have neurological deficits.
Not a fit: Patients with cerebral hemorrhage or those who cannot undergo flexible endoscopic evaluation due to lack of alertness or compliance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and management of swallowing difficulties in stroke patients, potentially reducing complications and mortality.
How similar studies have performed: The TEDRAS-Trial has shown initial success in identifying dysphagia risks associated with TEE, making this follow-up study a continuation of a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute cerebral infarction detected by cMRI or cCT * Indication for TEE * Neurological deficits * Written informed consent Exclusion Criteria: * Cerebral hemorrhage * Contraindications to FEES (lack of alertness as well as lack of compliance)
Where this trial is running
Giessen, Hesse
- University Hospital Giessen and Marburg — Giessen, Hesse, Germany (Recruiting)
Study contacts
- Principal investigator: Samra Hamzic, Dr — University Hospital Giessen and Marburg, Campus Giessen
- Study coordinator: Samra Hamzic, Dr
- Email: samra.hamzic@neuro.med.uni-giessen.de
- Phone: +4917699807230
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.