Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-29 @ 11:03 AM
Study NCT ID:
NCT07195968
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-29
First Post:
2025-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa (CANS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-18', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-09-18', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Target vessel failure', 'timeFrame': '3 years', 'description': 'The target vessel failure included target vessel myocardial infarction, target vessel restenosis or revascularization.'}], 'primaryOutcomes': [{'measure': 'Absolute difference between NTG-Pd/Pa and Saline-Pd/Pa value', 'timeFrame': '3 minutes', 'description': 'The absolute difference was calculated as the Saline-Pd/Pa value minus the NTG-Pd/Pa value.'}], 'secondaryOutcomes': [{'measure': 'Diagnostic performance of NTG-Pd/Pa and Saline-Pd/Pa', 'timeFrame': '4 minutes', 'description': 'To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR≤0.80.'}, {'measure': 'Repeatability of Saline-Pd/Pa', 'timeFrame': '2 minutes', 'description': 'Saline-Pd/Pa will be measured at one-minute intervals, and the absolute differences between consecutive measurements will be analyzed.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Fractional flow reserve', 'NTG-Pd/Pa', 'Saline-Pd/Pa'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to compare the value of NTG-Pd/Pa and saline-Pd/Pa in participants with intermediate stenosis of the coronary artery. The main questions it aims to answer are:\n\nThe numerical difference between NTG-Pd/Pa and saline-Pd/Pa To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment?\n\nParticipants will undergo NTG-Pd/Pa, Saline-Pd/Pa, and FFR successively in the target vessel.', 'detailedDescription': 'Fractional Flow Reserve (FFR) is the gold standard for determining the functional ischemia of coronary arteries with intermediate lesions. Both intracoronary nitroglycerine (NTG) administration and saline administration induce an acute drop in trans-lesional coronary pressure. Both pressure ratios correlate well with FFR values and can reliably predict positive results in FFR assessments. The aims of this study were\n\n1. To evaluate the numerical difference between NTG-Pd/Pa and saline-Pd/Pa.\n2. To test the repeatability of saline-Pd/Pa.\n3. To compare the diagnostic performance of NTG-Pd/Pa and saline-Pd/Pa in predicting the binary result of FFR assessment.\n\nParticipants will be enrolled prospectively from National Taiwan University Hospital Hsinchu Hospital, Miaoli General Hospital, and Taichung Veterans General Hospital. The coronary artery with intermediate stenosis will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants referred for coronary angiography with intermediate lesions will be invited to join the registry. Enrollment sites include medical facilities in northern and central Taiwan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with coronary artery with 50-90% stenosis.\n* In participants who suffered from ST elevation myocardial infarction within 5 days, only the non-culprit vessel was eligible for coronary functional testing.\n\nExclusion Criteria:\n\n* Systolic blood pressure is less than 90 mmHg for more than 5 minutes during examination.\n* Resting heart rate is less than 50 beats per minute.\n* Heart failure remains decompensated at the time of examination, such as inability to lie flat or cardiogenic shock.\n* Acute onset of asthma or chronic obstructive pulmonary disease.'}, 'identificationModule': {'nctId': 'NCT07195968', 'briefTitle': 'Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa (CANS)', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'A Prospective, Multicenter Study: Comparative Analysis of NTG-Pd/Pa and Saline-Pd/Pa', 'orgStudyIdInfo': {'id': '202507242RINB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort A', 'description': 'Participants will undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments sequentially. Saline-Pd/Pa will be tested repeatedly during the assessment.', 'interventionNames': ['Diagnostic Test: NTG-Pd/Pa measurement', 'Diagnostic Test: Saline-Pd/Pa measurement']}], 'interventions': [{'name': 'NTG-Pd/Pa measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'The coronary artery with intermediate stenosis will sequentially undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments. Intracoronary NTG dosage will follow the protocol based on blood pressure.', 'armGroupLabels': ['Cohort A']}, {'name': 'Saline-Pd/Pa measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'The coronary artery with intermediate stenosis will sequentially undergo NTG-Pd/Pa, saline-Pd/Pa, and FFR assessments. Ten millilitres of intracoronary saline will be given over five seconds.', 'armGroupLabels': ['Cohort A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30047', 'city': 'Hsinchu', 'state': 'Select', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Hsin-Chu Hospital', 'geoPoint': {'lat': 24.80361, 'lon': 120.96861}}, {'zip': '36054', 'city': 'Miaoli', 'country': 'Taiwan', 'facility': 'Miaoli General Hospital, Ministry of Health and Welfare', 'geoPoint': {'lat': 24.56427, 'lon': 120.82367}}, {'zip': '407219', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Chien Boon Jong, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital, Hsin-Chu Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data cannot be shared publicly because of ethical restrictions. The restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are from the National Taiwan University Hospital Ethics Committee (contact via ntuhrec@ntuh.gov.tw) for researchers who meet the criteria for access to confidential data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Miaoli General Hospital, Ministry of Health and Welfare, Taiwan', 'class': 'UNKNOWN'}, {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}