Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01257880 · ClinicalTrials.gov registry record
Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP)
A clinical trial of Patent Foramen Ovale and Migraine With Aura, sponsored by Swedish Medical Center.
- Completed
- Registry status
- 31
- Enrollment target
- 2
- Study locations
NCT01257880: Completed study of Patent Foramen Ovale and Migraine With Aura, sponsored by Swedish Medical Center.
NCT01257880 is a study of Patent Foramen Ovale and Migraine With Aura that has completed, run by Swedish Medical Center. The registered enrollment target is 31 participants, below the 417-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01257880, a study of Patent Foramen Ovale and Migraine With Aura, has completed, sponsored by Swedish Medical Center.
- COMPLETED
- Registry status
- 31 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of the study is to compare the rate of comorbidities associated with migraine aura (MA) between persons who have a large circulatory right-to-left shunt (RLS) and those who do not have RLS. Approximately 50% of individuals who have MA also have RLS due to patent foramen ovale (PFO). A PFO is an anatomical opening or flap between the upper chambers of the heart or atria that permits blood to pass from the right of the heart to the left side of the heart, without first going to the lungs to be filtered and oxygenated. Many health conditions and clinical syndromes including stroke, sleep apnea, and migraine have been linked to PFO. Although the mechanism is undetermined, it is hypothesized that microscopic blood clots and chemicals such as serotonin can pass through the PFO, travel to the brain, and cause headache and aura. Persons who have MA are at increased risk for stroke and transient ischemic attacks relative to people who do not have migraine. Migraine is also associated with the presence of white matter lesions in the brain and mild deficits in cognitive function associated with the posterior brain (vision, memory, processing speed). The risk of stroke in migraine is highest for women under the age of 45 who have aura and a high number of migraine headache days per month. No convincing evidence has been produced to explain the mechanism for the increased risk of ischemic stroke in migraine; however, increased platelet activation and aggregation is a plausible theory. We hypothesize that migraineurs with aura and large RLS (presumably due to a PFO) will be more likely to have sleep apnea, increased platelet activation, cognitive deficits, alterations in cerebral vasomotor function, and white matter lesions than migraineurs with aura who do not have PFO. The results of this exploratory study will generate hypotheses as to why subgroups of migraineurs have an increased risk of stroke and the impact of large PFO on comorbid conditions associated with
Primary Outcome
Embolic tracks on transcranial Doppler at rest and following calibrated Valsalva maneuver
Conditions Studied
Study Locations (2)
Washington
- Swedish Medical Center - Seattle
- The University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-01 |
| Est. Completion | 2011-05 |
What the finished NCT01257880 record still lists
NCT01257880 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 417-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Patent Foramen Ovale appearing as the primary indexed condition, and to 0 interventions.
NCT01257880 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT01257880 about?
NCT01257880 is a clinical study titled "Comorbidities Associated With Migraine and Patent Foramen Ovale (CAMP)". The purpose of the study is to compare the rate of comorbidities associated with migraine aura (MA) between persons who have a large circulatory right-to-left shunt (RLS) and those who do not have RLS. Approximately 50% of individuals who have MA also have RLS due to patent foramen ovale (PFO). A P...
What is the current status of trial NCT01257880?
This trial is currently completed. The enrollment target is 31 participants. The study started on 2010-01. Estimated completion is 2011-05.
What conditions does trial NCT01257880 study?
This clinical trial studies the following conditions: Patent Foramen Ovale, Migraine With Aura.
Who is sponsoring clinical trial NCT01257880?
This trial is sponsored by Swedish Medical Center, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01257880 being conducted?
This trial has 2 study locations across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Patent Foramen Ovale
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Encore PFO Closure Device - The PerFOrm Trial
RECRUITING · NA
-
Early Feasibility Study (EFS) Evaluating Percutaneous Repair of the Atrial Septum With a Novel PFO Occluder: The PROTEA-PFO Study
RECRUITING · NA
-
AMPLATZER PFO Occluder Post Approval Study
ACTIVE NOT RECRUITING · NA
-
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
ACTIVE NOT RECRUITING · NA
-
Is Blood Flow Through IPAVA and PFO Related to Breath-hold and SCUBA Diving-induced Pulmonary Hypertension?
COMPLETED · Early Phase 1
-
Does Patent Foramen Ovale Size Matter in Men and Women
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02932618 · 31 participants · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
- NCT03482297 · 31 participants · Phase 1
Automated Abdominal Binder for Orthostatic Hypotension
- NCT04016389 · 31 participants · NA
FIGO 2018 Stage IB2 Cervical Cancer Treated With Neoadjuvant Chemotherapy Followed by Fertility Sparing Surgery
- NCT04211675 · 31 participants · Phase 1
NK Cells Infusions With Irinotecan, Temozolomide, and Dinutuximab
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia