Is your site interested in joining SECRETO?
First, please check that your site fulfills the site criteria defined in the study protocol:
- Rapid access to an MRI scanner with a minimum magnet field strength of 1.5 Tesla and a slice thickness of 5 mm or less
- Ability to perform the recommended brain and vascular imaging protocol as part of routine clinical care
- Ability to perform the recommended cardiac examination protocol in patients as part of routine clinical care
- Ability to provide requested brain, vascular, and cardiac imaging data in DICOM format burned onto a DVD
- Capability to analyze the recommended set of routine laboratory tests and coagulopathy screening in patients in a local laboratory (N.B. incomplete set of tests does not preclude participation if some of the tests are not reimbursed from local insurances)
- Ability to provide electrocardiogram (ECG) in digital format (naïve digital or scanned and saved as PDF format)
- Laboratory facilities necessary for processing and storing (for at least 6-12 months) investigational blood samples prior to shipment to core laboratory: access to centrifuge and -70°C (or below) freezer
- Transportation of biospecimens to another country for storage or analysis is permitted according to local regulations/legislation
Please contact the Coordinating Center via email at contact[at]secretostudy.net or by using the contact form.
We will send you an email with instructions on how to access the study documentation needed for ethics approval as well as other study material, including questionnaires and SOP documents.
After we have received your ethics approval via email, we will send you a second email with Collaboration Agreement and a link to a secured survey where details listed below are queried. The ethics approval may be mandatory prior to answering these questions (one ethics approval per country may be sufficient). We strongly recommend obtaining ethics approval for the main study and Family Study substudy (if applicable) at the same time.
- Estimated annual number of study subjects to be recruited at the site
- Contact information of the site principal investigator, co-investigators (including neurologist and cardiologist/clinical physiologist), and other study personnel (study nurse).
- You will also be asked, who will participate in the eCRF data entry.
- Decision on whether your site participates in the Family Study (substudy)
- Decision on whether stroke-free control subjects will be screened for right-to-left shunt (TCD bubble test or other noninvasive screening method) and/or echocardiography examination.
We must receive a wet-signed copy of the Collaboration Agreement. Please post it to the Coordinating Center.
Please email each investigator’s CV and neurologist co-investigator’s certificates on passed exams of the modified Rankin Scale and NIH Stroke Scale (should not be older than 3 years). Please verify via email that cardiologist/clinical physiologist co-investigator has reviewed the Echocardiography Performance Protocol and Echocardiography eLearning material.
After we have received all documents along with the signed Collaboration Agreement, we will assign your site ID and provide login credentials for online database.
We will then send you a package containing materials for blood sampling, sample processing, and storage, as well as empty DVDs for recording brain/vascular imaging and echocardiography studies as well as preaddressed padded envelopes.
After familiarized with the SOP documents you are ready to enroll your first patient!