Mild and Rapidly Improving Stroke Study MaRISS

  • STATUS
    Recruiting
  • sponsor
    American Heart Association
Updated on 25 March 2021

Summary

Mild and Rapidly Improving Stroke Study MaRISS

Description

MaRISS is a prospective observational study to define the 90-day outcomes of patients with mild and/or rapidly improving stroke by a telephone-based assessment of stroke outcomes based on established and validated measures including the mRS, BI, SIS-16 and EuroQOL. The efficacy and safety outcomes of patients with mild and improving strokes treated with thrombolytics will be explored by comparing them to those treated conservatively without thrombolytics.

Please contact Candida Barlow, Director, St. John Clinical Research Institute
1725 E. 19th St. Suite 701
Tulsa, OK 74104
Office: 918-744-3426 Fax: 918-403-0018
Email: candida.barlow@ascension.org

Details
Clinical Study IdentifierTX151544
SponsorAmerican Heart Association
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients with mild or spontaneously rapidly improving acute ischemic stroke defined clinically. Mild stroke is defined as an NIHSS 0-5. MaRISS does not define Rapidly Improving Stroke Symptoms for purposes of enrollment. It enrolls patients after the determination to treat or not to treat has been made, in order not to influence treatment decisions
Absence of non-ischemic conditions on neuro-imaging (i.e. absence of hemorrhage or a mass on non-contrast brain CT, or more advanced imaging obtained according to participating site’s imaging protocol)
Age 18 years or older
Arrival to the hospital within 4.5 hours after the onset of stroke symptoms
Patient or legally authorized representative provides consent within 24 hours of arrival. Obtaining consent beyond 24h will be allowed if the patient arrived to the hospital within 4.5 hours of the onset of symptoms and the NIHSS is performed as standard of care at 24 hours +/- 4 hours from onset of symptoms (or before if the patient has neurological deterioration) by a certified practitioner and provided that the NIHSS sub-scores information is readily available and can be recorded in the participant’s study record
Available by telephone and willing to receive two follow-up telephone calls over the next 3 months

Exclusion Criteria

Acute stroke patients arriving to the hospital beyond 4.5 hours from symptom onset
Unable to obtain consent from either patient or legally authorized representative
Pre-morbid modified Rankin scale greater than 1
Not available by telephone
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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