Clinical Trial Details

Overview

Research Study Summary

Mild and Rapidly Improving Stroke Study MaRISS

Purpose

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.

To Learn more

CW ID: 225844
Date Last Changed: August 3, 2017

Clinical Trial Snapshot

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
American Heart Association
Duration
90 Days
Facility Type
Out-Patient

Eligibility

Inclusion criteria:
  1. 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.
  2. 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).
  3. Age 18 years or older.
  4. Arrival to the hospital within 4.5 hours after the onset of stroke symptoms.
  5. 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.
  6. Available by telephone and willing to receive two follow-up telephone calls over the next 3 months.
Exclusion Criteria:
  1. Acute stroke patients arriving to the hospital beyond 4.5 hours from symptom onset.
  2. Unable to obtain consent from either patient or legally authorized representative.
  3. Pre-morbid modified Rankin scale greater than 1.
  4. Not available by telephone.

More Info

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

Contact

Candida Barlow, MSN RN, Director of St. John Clinical Research Institute
St. John Clinical Research Institute
1725 E. 19th St. Suite 701
Tulsa, OK 74104
Phone: 918-744-3426

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Research Center Information:

St. John Clinical Research Institute

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