Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2026-04-10 @ 10:16 AM
Study NCT ID:
NCT02784912
Status:
UNKNOWN
Last Update Posted:
2017-06-08
First Post:
2016-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D017180', 'term': 'Tachycardia, Ventricular'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'From each patient will be collected 10 ml of venous blood which will be centrifurgated to obtain serum.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-07', 'studyFirstSubmitDate': '2016-05-21', 'studyFirstSubmitQcDate': '2016-05-24', 'lastUpdatePostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Correlation of serum biomarkers concentrations with cardiac remodeling.', 'timeFrame': 'up to 12 months'}, {'measure': 'Correlation of serum biomarkers concentrations with hemodynamic stress.', 'timeFrame': 'up to 12 months'}, {'measure': 'Assessment of iron deficiency and its prognostic significance.', 'timeFrame': 'up to 12 months'}, {'measure': 'Assessment of changes in biomarker levels in serial measurements.', 'timeFrame': 'up to 12 months'}, {'measure': 'Correlation of serum biomarkers concentrations in patients with and without device (ICD or CRT-D) already implanted.', 'timeFrame': 'up to 12 months'}, {'measure': 'Correlation of serum biomarkers concentrations with a size of an infarct scar.', 'timeFrame': 'during index hospitalization'}], 'primaryOutcomes': [{'measure': 'Biomarker-related risk stratification of composite endpoint (cardiovascular death or rehospitalization, arrhythmia recurrence) occurrence after ablation of sustained ventricular tachycardia or electrical storm.', 'timeFrame': 'up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Biomarker-related risk stratification of secondary endpoint (all-cause death or rehospitalization, intensification of atrial arrhythmia) occurrence after ablation of sustained ventricular tachycardia or electrical storm.', 'timeFrame': 'up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Biomarkers', 'Ventricular Dysfunction', 'Ventricular Tachycardia', 'Electrical Storm', 'ST2', 'Galectin-3', 'NT-proBNP', 'Iron Deficiency', 'hs-CRP', 'hs-TnT'], 'conditions': ['Heart Failure', 'Ventricular Tachycardia', 'Ventricular Dysfunction']}, 'descriptionModule': {'briefSummary': 'Prevalence of HF reaches 1-2% of developed populations, and consequently a significant problem becomes more frequent occurrence of ventricular arrhythmias (VA) - sustained ventricular tachycardia (sVT) and electrical storm (ES) requiring radiofrequency ablation.\n\nThe aim of the study is to create a model of risk stratification to identify patients with increased risk of occurrence of composite (cardiovascular death or rehospitalization, arrhythmia recurrence) and secondary (inadequate device therapy, all-cause death or rehospitalization, intensification of atrial arrhythmia) endpoints after ablation of ES or sustained VT. Model will be based on additional measurements of N-terminal pro brain natriuretic peptide (NT-proBNP), Galectin-3, suppressor of tumorigenicity 2 (ST2), high sensitive troponin T (hs-TnT), high sensitive C-reactive protein (hs-CRP), iron deficiency to clinical-, electrocardiographic- and echocardiographic assessment.', 'detailedDescription': 'Patients with ischemic heart failure (HF) and reduced left ventricle ejection fraction are at high risk for recurrence of VA, ultimately leading to death. Such patients often require ablation. On the other hand, ablation of the VA in patients with post-infarction scar is a technically difficult procedure and often is associated with short-term efficacy.\n\nRisk factors for recurrence of VA are difficult to identify, although there are mentioned e.g. reduced left ventricular ejection fraction, exacerbation of chronic HF and electrolyte abnormalities.\n\nVA is triggered by ongoing inflammation and fibrosis, which are reflected by a level of biomarkers. Thus, it is worth searching for biomarkers that increase the possibility of effective stratification of risk of arrhythmia recurrence in patients undergoing ablation of sVT or ES.\n\nThe hypothesis of this study is that biomarker-related risk stratification may be beneficial for patients with ES or sVT.\n\nSample size assessment was made to specify the number of participants necessary to demonstrate an effect.\n\nThe study will include at least 50 patients (who meet the inclusion/exclusion criteria) with ischemic heart failure, with reduced left ventricle ejection fraction admitted to hospital and qualified for ablation due to ES or sVT.\n\nFor every patient will be provided case report forms (CRFs) including their clinical status at admission and at discharge, laboratory findings, management during index hospitalization, data from ablation procedure, pharmacotherapy, as well as in-hospital and one-year outcome.\n\nSerum will be collected before ablation and 1-month after discharge from hospital for biomarkers measurements. Patients will be tele-monitored for ≥12-months. There will be carried out two control visits (including assessment of clinical, echocardiographic, electrocardiographic and Holter-ECG parameters) on 1- and 3 months after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study will include patients with ischemic heart disease with reduced left ventricle ejection fraction admitted to hospital and qualified for ablation due to electrical storm or sustained ventricular tachycardia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (all required):\n\n* \\>= 18 years\n* signed consent\n* ischemic heart disease\n* left ventricle ejection fraction \\<= 35%\n* admission to hospital due to electrical storm or sustained ventricular tachycardia and qualification for ablation of the arrhythmia\n* patients with already implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy defibrillator (CRT-D) or patients qualified for implantation\n\nExclusion Criteria:\n\n* non-ischemic heart disease\n* current ischemia and potentially reversible causes (e.g. electrolyte abnormalities, drug intoxication) of the arrhythmia\n* congenital genetic heart disease\n* serious comorbidities (e.g. neoplasm)\n* chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatoid arthritis)\n* renal failure (creatinine \\>2,5 mg/dl)'}, 'identificationModule': {'nctId': 'NCT02784912', 'acronym': 'STORM', 'briefTitle': 'Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Biomarkers-related riSk sTratification of Arrhythmia Recurrence in Patients undergOing Ablation of Sustained ventRicular Tachycardia or Electrical storM - STORM Study', 'orgStudyIdInfo': {'id': 'STORM'}}, 'contactsLocationsModule': {'locations': [{'zip': '02-097', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'contacts': [{'name': 'Krzysztof Ozierański, MD', 'role': 'CONTACT', 'email': 'krzysztof.ozieranski@gmail.com', 'phone': '509 996 947', 'phoneExt': '0048'}, {'name': 'Paweł Balsam, PhD', 'role': 'CONTACT', 'email': 'pawel.balsam@me.com', 'phone': '605 152 120', 'phoneExt': '0048'}, {'name': 'Krzysztof Ozierański, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paweł Balsam, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcin Grabowski, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Piotr Lodziński, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michał Peller, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Agata Tymińska, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Grzegorz Opolski, Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': '1st Department of Cariology of Medcial University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Krzysztof Ozierański, MD', 'role': 'CONTACT', 'email': 'krzysztof.ozieranski@gmail.com', 'phone': '509 996 947', 'phoneExt': '0048'}, {'name': 'Paweł Balsam, PhD', 'role': 'CONTACT', 'email': 'pawel.balsam@me.com', 'phone': '605 152 120', 'phoneExt': '0048'}], 'overallOfficials': [{'name': 'Marcin D Grabowski, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '1st Department of Cardiology Medical University of Warsaw'}, {'name': 'Piotr Lodzinski, PhD', 'role': 'STUDY_CHAIR', 'affiliation': '1st Department of Cardiology Medical University of Warsaw'}, {'name': 'Grzegorz Opolski, Professor', 'role': 'STUDY_CHAIR', 'affiliation': '1st Department of Cardiology Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The investigators will be able to share data for meta-analyses'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, Marcin Grabowski, Medical University of Warsaw', 'investigatorFullName': 'Marcin Grabowski', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}