Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02121028 |
|
Recruitment Status :
Recruiting
First Posted : April 23, 2014
Last Update Posted : February 28, 2018
|
Sponsor:
University of Miami
Collaborators:
University of California, Los Angeles
Northwestern University
Emory University
Baystate Medical Center
Information provided by (Responsible Party):
Jose Romano, MD, University of Miami
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 18, 2014 | |||||||||
| First Posted Date | April 23, 2014 | |||||||||
| Last Update Posted Date | February 28, 2018 | |||||||||
| Study Start Date | January 2015 | |||||||||
| Estimated Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Recurrent stroke in the territory of the symptomatic artery [ Time Frame: 1 year ] Time to ischemic stroke in the territory of the symptomatic artery. Stroke is ascertained by the site neurologist and defined as new or worsening symptoms lasting >24 hours and associated with imaging evidence of ischemia on CT or MRI in the distribution of the stenotic artery.
|
|||||||||
| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | Complete list of historical versions of study NCT02121028 on ClinicalTrials.gov Archive Site | |||||||||
| Current Secondary Outcome Measures |
|
|||||||||
| Original Secondary Outcome Measures |
|
|||||||||
| Current Other Outcome Measures |
|
|||||||||
| Original Other Outcome Measures | Same as current | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease | |||||||||
| Official Title | Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease | |||||||||
| Brief Summary | The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through the stenotic artery, distal tissue perfusion to the affected territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients will be studied within 21 days of the index event (allowing appropriate time to arrange for diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate mechanisms of recurrent ischemia:
Patients will receive standardized medical management and its effectiveness on blood pressure, lipid, and glycemic control will be monitored. The primary outcome is recurrent stroke in the territory of the stenotic artery during a 1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack (TIA) in the distribution of the stenotic artery during a 1-year follow-up period. Patients will be recruited at various sites that will be trained and certified on the imaging techniques employed. Raw imaging data will be interpreted centrally. |
|||||||||
| Detailed Description | Not Provided | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
|||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Eligible patients will have a recent stroke or TIA due to intracranial Atherosclerotic Disease (IAD) of 50-99% . | |||||||||
| Condition | Intracranial Vascular Disorders | |||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Intracranial Atherosclerotic Disease, Stroke/TIA
Stroke/TIA due to high grade IAD ≤21 days from symptom onset. |
|||||||||
| Publications * | Not Provided | |||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
175 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | December 2019 | |||||||||
| Estimated Primary Completion Date | April 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
|
|||||||||
| Sex/Gender |
|
|||||||||
| Ages | 30 Years to 99 Years (Adult, Senior) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
|
|||||||||
| Listed Location Countries | United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT02121028 | |||||||||
| Other Study ID Numbers | 20140056 | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement | Not Provided | |||||||||
| Responsible Party | Jose Romano, MD, University of Miami | |||||||||
| Study Sponsor | University of Miami | |||||||||
| Collaborators |
|
|||||||||
| Investigators |
|
|||||||||
| PRS Account | University of Miami | |||||||||
| Verification Date | February 2018 | |||||||||