Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04882657 |
| Other study ID # |
IIBSP-COL-2019-64 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
May 2021 |
| Source |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Contact |
Joan Martí-Fàbregas, MD, PhD |
| Phone |
+34935565986 |
| Email |
jmarti[@]santpau.cat |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Prospective multicenter study of consecutive patients with acute ischemic stroke and large
intracranial vessel occlusion in which a thorough and systematic evaluation of all variables
that may be related to the degree of collateral circulation is performed.
Description:
Introduction. In patients with an acute ischemic stroke due to a large-vessel intracranial
occlusion (LVO), the status of the colateral circulation (CC) is related to clinical outcome
and to the success of mechanical thrombectomy. However, CC is highly variable from patient to
patient.
Methods. An observational, prospective, multicenter study of 700 consecutive patients with
acute ischemic stroke and a LVO. Factors to be evaluated: 1) Modifiable: Vascular risk
factors, blood analysis, prior medications, vital constants (with emphasis on continuous
blood pressure monitoring), head position, metrics (time to admission, Computed tomography
(CT), groin puncture, end of procedure), 2) Non-modifiable: age, sex, completeness of Circle
of Willis, etiology, type of mechanical thrombectomy, plasma biomarkers, genetic/epigenetic
factors (a discovery phase with GWAs study and a replication phase). CC grade will be
assessed by the ASITN/SIR collateral score from CT-angiography (CTA) and the Digital
substraction angiography (DSA, when performed). Statistics: bivariate analyses and a logistic
regression to predict CC grade (poor versus good) and CC persistence comparing CTA with DSA
(4 possibilities: poor-poor, poor-good, good-poor, good-good).
Expected results. Our study may find markers of the CC status, facilitate the design of
clinical trials to improve CC grade, may find new therapeutic targets and new treatments to
enhance the beneficial effects of mechanical thrombectomy.
