Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-24 @ 8:25 AM
Study NCT ID:
NCT02127294
Status:
COMPLETED
Last Update Posted:
2016-01-13
First Post:
2014-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054092', 'term': 'Foramen Ovale, Patent'}, {'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D006344', 'term': 'Heart Septal Defects, Atrial'}, {'id': 'D006343', 'term': 'Heart Septal Defects'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast-enhanced Transcranial Doppler', 'timeFrame': 'within one year period', 'description': 'Patients in transcatheter closure group are required to perform contrast-enhanced Transcranial Doppler at 1 month, 3 month, 6 month and 1 year after closure, respectively.'}], 'secondaryOutcomes': [{'measure': 'Headache Impact Test-6', 'timeFrame': 'within one year period, at least 3 months', 'description': 'All patients complete HIT-6 score at baseline. Patients in transcatheter closure group follow-up at 1 month, 3 month, 6 month and 1 year after closure, respectively. Patients in contrast group follow-up twice during one year period.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Foramen Ovale, Patent', 'migraine', 'transcatheter patent foramen ovale closure', 'contrast-enhanced transcranial Doppler', 'Transthoracic Echocardiography'], 'conditions': ['Foramen Ovale, Patent', 'Migraine']}, 'referencesModule': {'references': [{'pmid': '22747847', 'type': 'BACKGROUND', 'citation': 'Yang Y, Guo ZN, Wu J, Jin H, Wang X, Xu J, Feng J, Xing Y. Prevalence and extent of right-to-left shunt in migraine: a survey of 217 Chinese patients. Eur J Neurol. 2012 Oct;19(10):1367-72. doi: 10.1111/j.1468-1331.2012.03793.x. Epub 2012 Jun 30.'}, {'pmid': '27966652', 'type': 'DERIVED', 'citation': 'Xing YQ, Guo YZ, Gao YS, Guo ZN, Niu PP, Yang Y. Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine (EASTFORM) Trial. Sci Rep. 2016 Dec 14;6:39081. doi: 10.1038/srep39081.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate effectiveness and safety of transcatheter patent foramen ovale closure for migraine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical history of migraine diagnosed by a neurologist according to the International Classification of Headache Disorders\n* Transcranial Doppler evidence of right-to-left shunt(RLS) and echocardiographic evidence of PFO，of which the degree is moderate to large RLS\n* Subjects who have not responded to or cannot take common migraine preventive medications\n* Willing to participate in follow-up visits\n\nAdditional Inclusion Criteria:\n\n* Transcatheter closure group: Closure of PFO is performed\n* Contrast group: Subjects who meet the Inclusion Criteria, but refuse to undergo closure procedure\n\nExclusion Criteria:\n\n* Seizure disorder\n* Other organic central nervous system disease\n* Subjects whose headaches are other than migraine, such as a result of traumatic head or neck injury\n* Evidence of alcohol, drug or substance abuse within the previous year\n\nAdditional Exclusion Criteria for Transcatheter closure group:\n\n* Subjects with intracardiac thrombus or tumor\n* Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina\n* Subjects with left ventricular aneurysm or akinesis\n* Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)\n* Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum\n* Subjects with contraindication to aspirin or Clopidogrel therapy\n* Pregnant or desire to become pregnant within the next year'}, 'identificationModule': {'nctId': 'NCT02127294', 'acronym': 'EASTFORM', 'briefTitle': 'Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine', 'orgStudyIdInfo': {'id': 'PFO-1shsf'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcatheter closure group', 'description': 'Migraine patients with patent foreman ovale (PFO)，who meet the criteria and agree to conduct closure of patent foramen ovale will be selected to this group.', 'interventionNames': ['Device: transcatheter patent foreman ovale closure']}, {'type': 'NO_INTERVENTION', 'label': 'Contrast group', 'description': "Migraine patients with PFO，who meet the criteria but don't agree to conduct closure of patent foramen ovale will be selected to this group."}], 'interventions': [{'name': 'transcatheter patent foreman ovale closure', 'type': 'DEVICE', 'armGroupLabels': ['Transcatheter closure group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'overallOfficials': [{'name': 'Yi Yang, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Hospital of Jilin University'}, {'name': 'Yingqi Xing, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Hospital of Jilin University'}, {'name': 'Yuzhu Guo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yi Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associated Dean of First Hospital of Jilin University', 'investigatorFullName': 'Yi Yang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}