Cardiac Imaging Of Neuro-Embolic Mechanisms In Atriopathies Causing Stroke (CINEMAS)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 24-009294
- Rochester, Minnesota: 24-009294
About this study
The purpose of this study is to identify clinical factors and mechanisms associated with cardioembolic stroke related to atrial cardiopathy, hypothesizing that impaired left atrial appendage (LAA) velocities and stasis are key determinants.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Groups 1-2
- Stroke in one of the pre-defined categories for Groups 1-2.
- Signed informed consent from participant or legally authorized representative (LAR).
- Stroke onset to enrollment window 60 days: this time window allows for completion of potential acute inpatient rehabilitation, as it is difficult to arrange transport from an inpatient facility to outpatient MRI.
- Age ≥65 years
Groups 3-4
- Controls without stroke – without or with atrial fibrillation, matched, respectively, with Groups 1 and 2 (without and with atrial fibrillation).
- Matching criteria are: Age (±5 years); Sex; Race/Ethnicity; and CHA₂DS₂-VASc Score (excluding stroke).
- Signed informed consent from participant.
Exclusion Criteria:
- Patients not discharged to home or acute inpatient rehabilitation: patients discharged to a nursing home or assisted living facility may have difficulty returning for cardiac MRI.
- Contraindications to cardiac MRI, including MRI-incompatible metallic implants, implanted electronic devices (i.e. pacemaker/defibrillator, neurostimulators, cochlear implants), other potentially mobile ferromagnetic material (i.e. shrapnel, magnetic aneurysm clips) and morbid obesity, and those with severe claustrophobia or who are unable to lie flat for 30-60 minutes. In a previous stroke imaging study (Romano JG, Prabhakaran S, Nizam A, et al. Infarct recurrence in intracranial atherosclerosis: Results from the MyRIAD Study. J Stroke Cerebrovasc Dis. 2021;30:105504), we identified that only 4% of our ischemic stroke population had MRI contraindication. Of note, implantable loop recorders are not contraindicated as they are MRI compatible.
- Women who are pregnant, breast-feeding or intend to become pregnant.
- Anticipated life expectancy <1 year, as we anticipate minimum cardiac rhythm monitoring of 1 year and repeat cardiac MRI in a proportion of participants.
- Participation in other clinical trial involving investigational devices as these may not be MRI compatible and may interfere with cardiac rhythm monitoring.
- Patent foramen ovale (PFO) felt to be pathogenic as the cause of stroke: these individuals may be referred for PFO closure; it is unclear how this affects MRI 4D flow imaging.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 08/23/2024. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator James Meschia, M.D. |
Contact us for the latest status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jeremy Collins, M.D. |
Open for enrollment |
|
More information
Publications
Publications are currently not available