Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-01-27 @ 9:36 AM
Study NCT ID:
NCT02374359
Status:
UNKNOWN
Last Update Posted:
2015-02-27
First Post:
2015-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Tachycardia as a Predictor of Atrial Fibrillation, Stroke and Mortality in Cryptogenic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-02-26', 'studyFirstSubmitDate': '2015-02-23', 'studyFirstSubmitQcDate': '2015-02-26', 'lastUpdatePostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ischemic stroke', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'atrial fibrillation', 'timeFrame': '12 months'}, {'measure': 'cardiovascular mortality', 'timeFrame': '12 months'}, {'measure': 'global mortality', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cryptogenic Stroke', 'Atrial Fibrillation', 'Atrial Tachycardia']}, 'descriptionModule': {'briefSummary': 'There is few information about the association between supraventricular arrhythmia different from atrial fibrillation (AF) or atrial Flutter and the risk of stroke. In this study the investigators hypothesized that the presence of atrial tachycardia would lead to atrial fibrillation and recurrent stroke in patients hospitalized for cryptogenic stroke.\n\nThe investigators study the association of atrial tachycardia (AT), defined as four or more consecutive premature atrial beats, and AF, recurrent stroke and cardiovascular mortality in 192 consecutive patients hospitalized because of cryptogenic stroke. The follow-up was 12 months for all population', 'detailedDescription': 'The investigators review all consecutive patients that were hospitalized from stroke in our hospital (Neurology department) between January 2010 and September 2013, and who had the diagnosis of cryptogenic stroke at discharge. All patients routinely underwent 24-hour ECG recording and an echocardiography during the hospitalization. The investigators have a global population of 210 patients who met these characteristics.\n\nThe investigators analyze the presence of atrial tachycardia in 24-hour ECG register in patients with cryptogenic stroke. The investigators consider atrial tachycardia as four or more consecutive atrial ectopic beats.\n\nThe investigators analyze baseline characteristics (cardiovascular risk factors, renal function, left atrial size \\_measured in M mode echocardiography in long paraesternal axis\\_ and total number of premature atrial complexes in the 24-hour ECG monitoring.\n\nThe patients are stratified according to the presence or absence of atrial tachycardia in 24-hour ECG data.\n\nThe investigators follow the clinical events (AF, recurrent stroke or death) of patients from the electronical medical data of general physician and the re-hospitalizations for recurrent ictus in our hospital (which is the reference hospital of the zone) and mortality during 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We review all consecutive patients that were hospitalized from stroke in our hospital (Neurology department) between January 2010 and September 2013, and who had the diagnosis of cryptogenic stroke at discharge', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients that were hospitalized from stroke in our hospital (Neurology department) between January 2010 and September 2013, and who had the diagnosis of cryptogenic stroke at discharge\n\nExclusion Criteria:\n\n* Patients with non-cryptogenic stroke\n* Patients with haemorragic stroke\n* Patients with terminal disease'}, 'identificationModule': {'nctId': 'NCT02374359', 'briefTitle': 'Atrial Tachycardia as a Predictor of Atrial Fibrillation, Stroke and Mortality in Cryptogenic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Atrial Tachycardia as a Predictor of Atrial Fibrillation, Stroke and Mortality in Cryptogenic Stroke', 'orgStudyIdInfo': {'id': 'CPTCAR-EP201501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'atrial tachycardia group', 'description': 'Patients diagnosed of cryptogenic stroke with atrial tachycardia in holter', 'interventionNames': ['Other: follow-up']}, {'label': 'Non atrial tachycardia group (control group)', 'description': 'Patients diagnosed of cryptogenic stroke with a normal holter', 'interventionNames': ['Other: follow-up']}], 'interventions': [{'name': 'follow-up', 'type': 'OTHER', 'armGroupLabels': ['Non atrial tachycardia group (control group)', 'atrial tachycardia group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08202', 'city': 'Sabadell', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Corporacio Sanitaria Parc Tauli', 'geoPoint': {'lat': 41.54329, 'lon': 2.10942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph', 'investigatorFullName': 'Elisabet Pujol-Iglesias', 'investigatorAffiliation': 'Corporacion Parc Tauli'}}}}