Greetings from the SECRETO Coordinating Center! We wish to thank you all for your cooperation and support thus far in this exciting journey to search explanations for early-onset cryptogenic strokes.
The ongoing year 2016 has already proven to be rewarding when it comes to opening new sites as now all five Finnish university hospitals are actively recruiting. We are also pleased to report that in addition to Istanbul and Lisbon, also Bergen is now ready to start recruitment — congratulations!
The beginning of this year has been successful not only in recruiting new patients but also in enrolling stroke-free control subjects. A total of 93 patients and 68 age-and-sex-matched control subjects have been enrolled by the end of March 2016 (see figure above).
The progress in recruitment of both patients and controls enables us to calculate more precise sample size estimations for each of the key objectives of the study — and calibrate the final sample size.
We are currently planning on preparing a manuscript describing the study protocol, accompanied by some initial pilot results and rationale for the sample size. At present, 600 matched case-control pairs seem feasible to be achieved by Q3-2018. Such a sample size enables most of the preplanned analyses to be conducted. That would mean a minimum of 8 additional recruiting sites, each recruiting an average of 32 case-control pairs.
Furthermore, we plan to submit a protocol abstract to poster sessions of ongoing clinical trials held in the forthcoming congresses, starting with the WSO’s World Stroke Congress in Hyderabad, India, in October 2016.
Genetic family study
In the meanwhile, we have been developing with Profs. Steven Kittner, John Cole, and Braxton Mitchell of the Medical School of University of Maryland an online scoring system to ease the identification of potentially genetically informative families (carrying several early-onset cardiovascular events) for the SECRETO Family Study. This is a substudy, which benefits from systematic case screening for the SECRETO main study, and is therefore best conducted in parallel.
Thus far, 9 informative families have been enrolled, blood samples of nearly all consenting family members collected, and pedigrees drawn. We plan to conduct an exome sequencing pilot study of the first families to be able to adjust the scoring algorithm and facilitate recruitment of new families at all centers expressing their interest.
How to activate your site?
Shortly said, before the 1st patient can officially be enrolled, the following points have to be organized:
- Send a copy of your local ethics committee approval to the Coordinating Center.
- Provide your site information by using a link sent to you.
- We provide you the site ID and login credentials for the online database. These will be sent via email from OpenClinica after receiving your details.
- Send the CVs as well as NIHSS and mRS certificates of all the participating team members to the Coordinating Center. We will reimburse the possible costs for the mRS certification (about 100 USD) after receiving the receipt and banking details.
After receiving the Site’s local ethics committee approval and Site information we will send you the contract to be signed.
Young stroke diagnostic work-up is all about close collaboration with echocardiographists
You may find it challenging to discuss the protocol with cardiologists or clinical physiologist at first, as it may look rather laborious on paper. However, after the first examinations, the entire protocol for TTE and TEE may take only about 20 minutes.
In addition, recent findings strongly suggest that most (or even nearly all) cryptogenic strokes can be of cardiac origin and thus, it is of utmost importance to get deeply into the heart of the matter. The only way to obtain high-quality structural and functional cardiac data in a multicenter study like SECRETO is to perform echo-studies according to step-by-step protocol and read the studies centrally. Such central reading absolutely necessitates the echo studies to be carried out carefully and according to the protocol at all times.
Scientific merits (e.g. authorships) will be granted to each collaborating cardiologist and/or clinical physiologist who contributes to the study and performs per-protocol echocardiographies.
So far, our journey has been extremely fascinating especially thanks to our highly motivated patients and controls. Our main focus right now is to open new sites to reach the project target in a reasonable time. We are prepared to continue our work in translating the study documents to facilitate implementation of SECRETO Study in several language areas. We are confident that great opportunities for scientific breakthroughs and meaningful findings await us in our investigations of young stroke patients! We are continuously seeking for new funding opportunities to bring this project to full bloom.
We warmly hank all active sites and invite new ones to join us in our team! Please do not hesitate to contact us in case of any further questions.