Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-27 @ 2:21 PM
Study NCT ID:
NCT03917251
Status:
WITHDRAWN
Last Update Posted:
2024-09-03
First Post:
2019-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D017566', 'term': 'Microvascular Angina'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI left the institution', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-29', 'studyFirstSubmitDate': '2019-03-03', 'studyFirstSubmitQcDate': '2019-04-15', 'lastUpdatePostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients that exhibit coronary microvascular resistance and dysfunction as reflected by FFR', 'timeFrame': 'Up to 12 months', 'description': 'Microvascular dysfunction with pacing'}], 'secondaryOutcomes': [{'measure': 'Patients that exhibit coronary microvascular resistance and dysfunction as reflected by CFR', 'timeFrame': 'Up to 12 months', 'description': 'Microvascular dysfunction with pacing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['coronary microvascular dysfunction'], 'conditions': ['Coronary Microvascular Disease', 'Cardiac Pacemaker Syndrome']}, 'descriptionModule': {'briefSummary': 'The study will examine role of transvenous pacing on coronary microcirculation.', 'detailedDescription': 'To study the role of transvenous pacing on the coronary microcirculation. This will be accomplished by gathering data from invasive Fractional Flow Reserve (FFR) and Coronary Flow Reserve (CFR) with and without ventricular pacing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients 19 years of age or older with clinical evidence of coronary ischemia undergoing coronary angiogram, and who have a pacemaker.\n\nExclusion Criteria:\n\n* Acute ST segment myocardial infarction\n* Known sensitivity or contraindication to the agents planned for administration during coronary angiography\n* Pacemaker dependent patients\n* Pregnancy\n* Hypotension (a systolic blood pressure lower than 90mmHg) that would preclude the administration of adenosine\n* Severe renal dysfunction, defined as a estimated glomerular filtration (eGFR) less than 30ml/min, confirmed by recent testing\n* Study subject has any underlying disorder that, in the opinion of the investigator, precludes them from giving informed consent at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT03917251', 'briefTitle': 'The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'The Effects of Trans Venous Cardiac Pacing on Coronary Microvascular Function and Hemodynamics', 'orgStudyIdInfo': {'id': '0898-18-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Right ventricular Pacemaker', 'description': 'Patients with right ventricular pacing and evidence of coronary ischemia who have evidence of coronary ischemia who are to undergo coronary angiogram.When an intermediate stenosis (40-80%) has been identified angiographically, this lesion will undergo further hemodynamic assessment, All data including resting flow, FFR, CFR, vital signs, arrhythmias and patient symptoms will be recorded twice: once when the pacemaker is programmed to pace, and once when the PPM is reprogrammed such that the pacemaker is no longer pacing.', 'interventionNames': ['Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacing']}, {'type': 'OTHER', 'label': 'Biventricular Pacemaker', 'description': 'Patients with Biventricular pacing and evidence of coronary ischemia who have evidence of coronary ischemia who are to undergo coronary angiogram.When an intermediate stenosis (40-80%) has been identified angiographically, this lesion will undergo further hemodynamic assessment, All data including resting flow, FFR, CFR, vital signs, arrhythmias and patient symptoms will be recorded twice: once when the pacemaker is programmed to pace, and once when the PPM is reprogrammed such that the pacemaker is no longer pacing.', 'interventionNames': ['Diagnostic Test: Coronary flow and pressure measurement in patients with ventricular pacing']}], 'interventions': [{'name': 'Coronary flow and pressure measurement in patients with ventricular pacing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Coronary flow and pressure measurement in patients with ventricular pacing', 'armGroupLabels': ['Biventricular Pacemaker', 'Right ventricular Pacemaker']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nashwa Abdulsalam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}