Clinical Prognosis After Stroke in Nonagenarian Patients Treated With Thrombolysis or Mechanical Thrombectomy
NCT ID: NCT04553237
Last Updated: 2023-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
111 participants
OBSERVATIONAL
2020-09-11
2023-04-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Neurological handicap in the elderly is due to a high rate of comorbidity, reduced neuronal plasticity, nutritional status, and the short time to convert the penumbra area to ischemia.
Currently the standard treatment for the acute phase of HF is thrombolysis or thrombectomy.
The principle of thrombolysis is based on the use of a thrombolytic drug (Actylise®). It is a tissue plasminogen activator (t-PA) that will cause lysis and dissolution of clots blocking the artery. Thrombolysis is recommended until 4:30 a.m. after the onset of symptoms in the absence of contraindication.
Mechanical thrombectomy consists of removing the blood clot by introducing a probe into the artery having a proximal carotid or sylvic occlusion in its M1 portion or in the vertebro-basilar territory of an indeterminate schedule of less than 24 hours or determined from 6 hours to 24 hours having a radio-clinical mismatch, according to the DAWN study. The results of this study were analyzed according to age, NIHSS score and lesion volume on perfusion scanner or MRI (RAPID software). The interim analysis at 31 months on 206 randomized patients (107 thrombectomies versus 99 medical treatments alone) showed a clear superiority of the thrombectomy, leading to the premature end of the study, over the handicap at 3 months with more than 35 % of independent patients.
In most of the randomized studies, patients over 90 years of age have been excluded or are under-represented. This lack of data therefore does not make it possible to determine the effectiveness of thrombolysis or thrombectomy treatments in these patients.
A recent meta-analysis has shown that the functional recovery in these patients treated by thrombectomy is superior to those of the same age without thrombectomies. According to American studies, the advanced age of a patient is not a contraindication to this treatment.
Patients affected by a cerebral infarction represent 40 to 50% of hospitalizations in the neurology department of the Groupe Hospitalier Paris Saint-Joseph. In the intensive care of the neuro-vascular unit, the patient is received as quickly as possible to decide whether he can benefit from an extreme emergency treatment (intravenous thrombolysis or thrombectomy).
The present study should show that the clinical course after treatment in patients over 90 years of age is substantially comparable to younger patients, and that age is not a contraindication to treatment in the acute phase of stroke in the elderly.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Construction of a Multidimensional Score for the Functional Prognosis of Cerebral Infarctions
NCT04802772
Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke
NCT04830436
The Experiences of Family Caregivers of Stroke Patients: A Cross-sectional Study of a French Cohort
NCT04741451
Involvement of the Physician in Primary Prevention and Pre-hospital Management of Stroke
NCT03975218
STAND: iSchemic sTroke evAluated at Bed Side With ultrasouND
NCT04180826
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients over 90 years old
No interventions assigned to this group
Patients between 70 and 89 years of age.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient treated in the neurology department of Paris Saint-Joseph hospital for a stroke between 2017 and 2019
* Patient treated by thrombolysis less than 4:30 after the onset of symptoms and / or by mechanical thrombectomy less than 24 hours.
* French-speaking patient
Exclusion Criteria
* Patient deprived of liberty
* Patient under legal protection
* Patient objecting to the use of their data for this research
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
IOANA BABICIU, MD
Role: PRINCIPAL_INVESTIGATOR
Fondation Hôpital Saint-Joseph
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Groupe Hospitalier Paris Saint-Joseph
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Murphy SL, Xu J, Kochanek KD, Curtin SC, Arias E. Deaths: Final Data for 2015. Natl Vital Stat Rep. 2017 Nov;66(6):1-75.
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24.
GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
Saposnik G, Cote R, Phillips S, Gubitz G, Bayer N, Minuk J, Black S; Stroke Outcome Research Canada (SORCan) Working Group. Stroke outcome in those over 80: a multicenter cohort study across Canada. Stroke. 2008 Aug;39(8):2310-7. doi: 10.1161/STROKEAHA.107.511402. Epub 2008 Jun 12.
Castonguay AC, Zaidat OO, Novakovic R, Nguyen TN, Taqi MA, Gupta R, Sun CH, Martin C, Holloway WE, Mueller-Kronast N, E English J, Linfante I, Dabus G, Malisch TW, Marden FA, Bozorgchami H, Xavier A, Rai AT, Froehler MT, Badruddin A, Abraham MG, Janardhan V, Shaltoni H, Yoo AJ, Abou-Chebl A, Chen PR, Britz GW, Kaushal R, Nanda A, A Issa M, Nogueira RG. Influence of age on clinical and revascularization outcomes in the North American Solitaire Stent-Retriever Acute Stroke Registry. Stroke. 2014 Dec;45(12):3631-6. doi: 10.1161/STROKEAHA.114.006487. Epub 2014 Oct 30.
Chandra RV, Leslie-Mazwi TM, Oh DC, Chaudhry ZA, Mehta BP, Rost NS, Rabinov JD, Hirsch JA, Gonzalez RG, Schwamm LH, Yoo AJ. Elderly patients are at higher risk for poor outcomes after intra-arterial therapy. Stroke. 2012 Sep;43(9):2356-61. doi: 10.1161/STROKEAHA.112.650713. Epub 2012 Jun 28.
Sharma JC, Fletcher S, Vassallo M. Strokes in the elderly - higher acute and 3-month mortality - an explanation. Cerebrovasc Dis. 1999 Jan-Feb;9(1):2-9. doi: 10.1159/000015889.
Sharobeam A, Cordato DJ, Manning N, Cheung A, Wenderoth J, Cappelen-Smith C. Functional Outcomes at 90 Days in Octogenarians Undergoing Thrombectomy for Acute Ischemic Stroke: A Prospective Cohort Study and Meta-Analysis. Front Neurol. 2019 Mar 20;10:254. doi: 10.3389/fneur.2019.00254. eCollection 2019.
To CY, Rajamand S, Mehra R, Falatko S, Badr Y, Richards B, Qahwash O, Fessler RD. Outcome of mechanical thrombectomy in the very elderly for the treatment of acute ischemic stroke: the real world experience. Acta Radiol Open. 2015 Sep 10;4(9):2058460115599423. doi: 10.1177/2058460115599423. eCollection 2015 Sep.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PCAT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.