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Clinical Prognosis After Stroke in Nonagenarian Patients Treated With Thrombolysis or Mechanical Thrombectomy (PCAT)

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ClinicalTrials.gov Identifier: NCT04553237
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

Stroke is a significant cause of death and disability in France and internationally. The incidence of stroke increases with age, equal for both sexes. Of all strokes, 50% of cases occur in patients over 75 years of age. This advanced age leads to a high risk of mortality, long hospitalization, causing neurological sequelae in most cases.

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.


Condition or disease
Stroke

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Study Type : Observational
Estimated Enrollment : 121 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Prognosis After Stroke in Nonagenarian Patients Treated With Thrombolysis or Mechanical Thrombectomy
Actual Study Start Date : September 11, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Group/Cohort
Patients over 90 years old
Patients between 70 and 89 years of age.



Primary Outcome Measures :
  1. Management of stroke between two groups of patients. [ Time Frame: Day 90 ]

    This outcome corresponds to the comparaison of functional recovery at D90 after a stroke as measured by the Modified Rankin scale for measuring the degree of disability or dependence in the daily activities of patients.

    0 - No symptoms.

    1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
    2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
    3. - Moderate disability. Requires some help, but able to walk unassisted.
    4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
    5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
    6. - Dead.


Secondary Outcome Measures :
  1. Symptomatic hemorrhagic changes [ Time Frame: Day 90 ]
    This outcome corresponds to the rate of patients with hemorrhagic transformation.

  2. Intra-hospital mortality [ Time Frame: Day 90 ]
    This outcome corresponds to the rate of patients with in-hospital mortality.

  3. Other complications [ Time Frame: Day 90 ]
    This outcome corresponds to the rate of patients presenting others complications during hospitalisation.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for stroke in the neurology department within the Groupe Hospitalier Paris Saint Joseph, between January 01, 2017 and December 31, 2019, i.e. 122 patients.
Criteria

Inclusion Criteria:

  • Patient over 70 years old
  • 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 under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under legal protection
  • Patient objecting to the use of their data for this research

Information from the National Library of Medicine

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): NCT04553237


Contacts
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Contact: IOANA BABICIU, MD 0144127841 ext +33 ibabiciu@ghpsj.fr
Contact: Helene BE, PharmD, pHD 0144127883 ext +33 crc@ghpsj.fr

Locations
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France
Groupe Hospitalier Paris Saint-Joseph Recruiting
Paris, France, 75014
Contact: IOANA BABICIU, MD    0144127841 ext +33    ibabiciu@ghpsj.fr   
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: IOANA BABICIU, MD Groupe Hospitalier Paris Saint Joseph
Publications of Results:

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT04553237    
Other Study ID Numbers: PCAT
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases