Trial Outcomes & Findings for Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis (NCT NCT03208166)

NCT ID: NCT03208166

Last Updated: 2019-10-07

Results Overview

Percent change CBF from baseline to 30 days as determined by ASL MRI imaging.

Recruitment status

COMPLETED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

Baseline and 30 days

Results posted on

2019-10-07

Participant Flow

Participant milestones

Participant milestones
Measure	Ischemic Conditioning Doctormate device is used daily. Doctormate: Ischemic conditioning device Usual Care: Standard medical care	Usual Care Standard medical care. Usual Care: Standard medical care
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Pre-Ischemic Conditioning for Intracranial Atherosclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ischemic Conditioning n=1 Participants Doctormate device is used daily. Doctormate: Ischemic conditioning device Usual Care: Standard medical care	Usual Care n=1 Participants Standard medical care. Usual Care: Standard medical care	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 0 • n=5 Participants	46 years STANDARD_DEVIATION 0 • n=7 Participants	55 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 30 days

Percent change CBF from baseline to 30 days as determined by ASL MRI imaging.

Outcome measures

Outcome measures
Measure	Ischemic Conditioning n=1 Participants Doctormate device is used daily. Doctormate: Ischemic conditioning device Usual Care: Standard medical care	Usual Care n=1 Participants Standard medical care. Usual Care: Standard medical care
Percent Change in Cerebral Blood Flow (CBF)	0 percentage increase in CBF	25 percentage increase in CBF

PRIMARY outcome

Timeframe: 30 days

Population: Since recruitment in the trial was terminated early and there were only 2 patients enrolled, one in the conditioning arm and one in the standard of care arm, a decision was made not to do these experimental biomarkers (which are done in batch) since interpretating the results would be challenging with just one patient in each arm.

Change in the absolute levels of the following biomarkers will be measured from baseline to 30 days: Nitrite, IL-10, SDF1, Micro RNA 144. Lp-PLA2, IL-6. hsCRP, Soluble E selectin, ICAm, MMP-9, PAI-1,tPA, ADMA

Outcome measures

Outcome data not reported

Adverse Events

Ischemic Conditioning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marc Chimowitz, MD

Medical University of South Carolina

Phone: 843-792-3020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place