Sub-Clinical Atrial Fibrillation Biomarker Study (SCAF-b)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02840201|
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : May 18, 2020
|Condition or disease|
|Subclinical Atrial Fibrillation|
Atrial fibrillation (AF) is the most common cardiac rhythm disorder worldwide, and is gaining in prevalence. Currently, the treatment for atrial fibrillation is concentrated on patients with existing atrial fibrillation, and the reduction in risks of complications of stroke with anticoagulation. Furthermore, mechanical interventions such as atrial ablation procedures are fraught with inconsistent results. The availability of serum based biomarkers that can predict the early onset of atrial fibrillation, and also the ability to prognosticate risk, may help in the identification of patients at risk for AF complications early. This would also allow the identification of the patient population most suitable for the evaluation of possible future intervention strategies to prevent the onset of atrial fibrillation, and alter its natural history and complications.
Currently the best biomarkers in predicting atrial fibrillation risk are in fact markers for heart failure - NTproBNP and high sensitivity troponin. These markers are independent from CHA2DS2-VASc score. While this is very helpful, these markers will not be able to distinguish these 2 conditions because heart failure and atrial fibrillation often co-exist. The investigator's Cardiovascular Biomarker Discovery and Translation team has been using deep proteomic analysis of both human tissues and reprogrammed human stem cells to identify novel candidate biomarkers. This has been very successfully applied to diastolic heart failure, and there are now several new markers for this condition that have been validated across 3 populations. The investigators have several potential candidates for atrial fibrillation, but validation in the appropriate cohort, particularly those at the earliest risks of atrial fibrillation, will be most important.
The ARTESiA study is an ideal study setting to perform the biomarker validation, as the parent trial will recruit patients with silent atrial fibrillation detected only by dual-chamber pacemakers, defibrillators or insertable cardiac monitors. This would constitute a potentially earlier stage atrial fibrillation patient cohort, with known subsequent risks in a prospective fashion. The prospective evaluation of approved medications of aspirin and apixaban will also be helpful to determine if the prospective biomarker will be informative of the potential efficacy of treatment, or be unchanged by the treatment modalities.
|Study Type :||Observational|
|Estimated Enrollment :||700 participants|
|Official Title:||Sub-Clinical Atrial Fibrillation Biomarker (SCAF-b): A Sub-study of Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA)|
|Actual Study Start Date :||June 26, 2017|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||July 2021|
- The burden of silent atrial fibrillation as recorded on implanted devices in patients [ Time Frame: 3 years ]as predicted by levels of proBNP, hsTnT and additional novel marker candidates
- The time related onset of complications [ Time Frame: 3 years ]complications include embolic stroke, cerebral hemorrhage, myocardial infarction, heart failure and cardiac death, as predicted by both novel and known biomarkers outlined above.
- Comparison of time related onset of complications between those receiving aspirin versus apixaban. [ Time Frame: 3 years ]complications such as embolic stroke, cerebral hemorrhage, myocardial infarction, heart failure and cardiac death will be compared between participants taking aspirin versus those taking apixaban
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840201
|Contact: Malaika Mohammed, B.A.S||613-696-7000 ext firstname.lastname@example.org|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Contact: Elizabeth Coletta, RN 613-696-7000 ext 10945 email@example.com|
|Principal Investigator:||Peter Liu, MD||Ottawa Heart Institute Research Corporation|