Sponsor: UNIVERSITY of MIAMI

Sponsor: UNIVERSITY of MIAMI

Mild and Rapidly Improving Stroke Study (MaRISS). Get with The Guidelines-Stroke Research Registry

Sponsor: UNIVERSITY OF MIAMI

Jose G. Romano, MD

Date: 04/04/2016

Summary of changes made to MaRISS study protocolv1.1 and v2.0

A)MaRISS study Protocol v1.1 (July 14th 2014) underwent the following editorial changes to provide more clarity and to update some of the statements.

  1. Section 4. Background and Rationale:
  1. Correction to the stroke statistics based on data published by the American Heart Association Statistics Committee and Stroke Statistics Subcommittee 2016 Update
  2. Editorial change made to add the word “not” in the first paragraph and the word “improving” in the fifth paragraph.
  3. Page 8:Second paragraph was modified to explain the recent revision of the alteplase prescribing information.
  1. Section 5. Study design and methods:

5.1Research plan: The statement “and confirmed by neuro imaging” was deleted. Only the absence of non-ischemic conditions on neuro-imaging is required.

5.3Study organization:The following changes were made:

  1. The American Heart Association staff roster and the MaRISS Steering Committee members were updated.
  2. Participating sites characteristics: It was clarified that exceptions to the required annual stroke discharge volume will be made on a case-by-case basis.
  3. Participating sites responsibilities: It was clarified that the Principal Investigator can designate an experienced practitioner to complete the TOAST classification.
  4. The restriction to enter the data in to GWTG-Stroke Registry within 15 days was deleted. It is not possible to determine exactly when the research data can be entered in the GWTG-Stroke Registry Research Tab since the patient’s information must be entered by the institution and a GWTG identification number must be created before the study data can be entered.

5.5Study Procedures:

  1. Summary: Clarification that the NIHSS should be performed at 24 hours +/- 4 hours of arrival.
  2. Eligibility criterion #5 was modified to clarify that obtaining informed 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 of arrival (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.
  1. Section 6. Specific Measurements and Outcomes:
  2. Defining Rapidly Improving Stroke: This section of the study protocol was modified to match the choices included in the Criteria for coding Rapidly Improving Stroke Data Collection Form (Attachment 7) and to provide examples.
  3. Assessing the NIHSS Score: Should be performed at 24 hours +/- 4 hours of arrival.
  4. Obtaining the TOAST classification: The TOAST classification can be done by an experienced practitioner designated by the study PI.
  1. Section 7. Evaluations and Data Collection:

7.1Study Flow Chart:A footer note was included to clarify the processes of obtaining Informed Consent beyond 24h and performing the NIHSS at 24 hours (+/- 4h of arrival).

7.3 MaRISS study Visits: The estimated time was adjusted for the telephone calls on Visit 4 and Visit 5 to “approximately 5-10 minutes” for the 30-day call and “approximately 20 minutes” for the 90day call.

  1. Section 11. References: The bibliographic references #1 and #19 were updated.
  1. Section 13: Attachments:
  1. A field for reporting the time the study assessment was performed was added to Attachment 5, the MaRISS NIH Stroke Scale Data Collection Forms. The date should be reported in the mm/dd/yy format; the page numbers were added as well.
  2. A new dedicated fax number was provided in the Attachment 11, MaRISS Adverse Event Reporting form.
  1. The following Participant’s facing material are included in this amendment submission for review:
  1. MaRISS 30-day follow up reminder letter
  2. MaRISS 30-day follow up reminder email
  3. MaRISS 90-day follow up reminder letter
  4. MaRISS 90-day follow up reminder email
  5. MaRISS follow up reminder text message
  6. MaRISS follow up cards

B)MaRISS Study Protocol v2.0 (January 18th2016)underwent the following editorial changes to provide more clarity and to update some of the statements.

  1. The time window allowed to perform the NIH Stroke Scale (NIHSS) for the 24-hour visit was corrected throughout the revised protocol. The NIHSS assessment should be done at 24 hours (+/- 4 hours) from the onset of symptoms.
  1. We updated the Study Roster by removing Stacey Graham as she is no longer part of the AHA MaRISS research team.
  1. Section 5.5 B-Eligibility Criteria; Section 6.1-Defining Mild Stroke, Section 6.2-Defining Rapidly Improving Stroke: Modification in language to provide a more precise explanation of what the study protocol regards as mild stroke and rapidly improving stroke.

No other modifications were made to the study protocol.

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