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- D-Dimer Assay, A Possible Tool in the Evaluation of Atrial Thrombosis Developing a biomarker approach to cardioembolic stroke risk prediction
Clinical Trial
D-Dimer Assay, A Possible Tool in the Evaluation of Atrial Thrombosis Developing a biomarker approach to cardioembolic stroke risk prediction
The study design will be prospective. Patients will be recruited from the Augusta University Medical Center, Augusta. We will identify 300 consecutive patients with possible intracardiac sources of thromboembolism including patients with cardiomyopathy, AF/AFL with onset greater than 48 hours, who are scheduled for Transesophageal echocardiography (TEE) in the Echo lab. TEE is a diagnostic procedure that uses sound waves (ultrasound) from a transducer to create an image of the heart. The sound waves bounce off the heart and echo back to a device called a transducer. This device changes the waves into a picture of the moving heart that can be seen on a video screen. Echocardiograms provide information about the heart?s structure and function. The principal investigator or a sub-investigator will recruit the patients.
Eligibility Criteria
- Inclusion criteria Signed informed consent and HIPAA documentation by subject or legally authorized representative, prior to participation in the study. Ages 18 years and above Subjects that meet one or more of the following categories and have a TEE ordered: Subjects with AF/AFL who are scheduled for TEE with or without subsequent cardioversion. Subjects with a known thromboembolic stroke scheduled for TEE with or without AF/AFL. Subjects whose TTE was suggestive of intracardiac clot and were scheduled for a confirmatory TEE. Subjects in the medical intensive care unit or coronary care unit with known AF/AFL in the last 7 days. Subjects with an ischemic stroke Subjects with a transient ischemic attack (TIA) There will be a group of control patients recruited who are low-risk for cardiac thromboembolism to assess whether or not biomarkers are able to exclude patients in this low-risk group. This will include patients undergoing PVC or SVT ablation with no symptoms or known pathology to suggest thromboembolism. Exclusion criteria A previous diagnosis of thromboembolic events in the last 2 months. Anticoagulation with Warfarin or IV Heparin for >48 hours. Those subjects receiving Direct-Acting Oral Anticoagulants (DOACs) will not be excluded. History of metastatic cancer, connective tissue disease, autoimmune disease, coagulation disorders. Patients who have a pacemaker. Patients who have hematoma. Patients with TTE or TEE results pointing to potential cardioembolic origin of stroke not treated with anticoagulation or antiplatelet (bacterial endocarditis, aortic fibroelastoma).