Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2026-02-28 @ 3:48 AM
Study NCT ID:
NCT02450318
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2015-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-05', 'studyFirstSubmitDate': '2015-05-18', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in endothelium-dependent dilation', 'timeFrame': 'Baseline, 15 minutes after exercise and 1 hour after exercise', 'description': 'Brachial artery endothelium-dependent flow-mediated dilation to reactive hyperemia will be measured using high resolution ultrasonography. To determine flow-mediated dilation, brachial artery diameter and blood velocity will be measured before and after occluding the forearm for 5 minutes by inflating a cuff to 250 mmHg.'}], 'secondaryOutcomes': [{'measure': 'Change in endothelium-independent dilation', 'timeFrame': 'Baseline, 15 minutes after exercise', 'description': 'To determine vascular smooth muscle responsiveness to nitric oxide, brachial artery diameter will be measured using high resolution ultrasonography before and after sublingual administration of 0.4mg nitroglycerin.'}, {'measure': 'Change in arterial stiffness and wave reflection', 'timeFrame': 'Baseline, 15 minutes after exercise and 1 hour after exercise', 'description': 'Aortic pulse wave velocity and augmentation index will be measured using applanation tonometry.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nonobstructive Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease.', 'detailedDescription': 'Women are more likely to have nonobstructive coronary artery disease (CAD) . The purpose of this study is to examine the acute effect of exercise on vascular function in women with nonobstructive coronary artery disease. Endothelium-dependent and -independent dilation, arterial stiffness and wave reflection will be measured at baseline and after walking on a treadmill at a slow pace for 47 minutes. Endothelium-dependent dilation will be measured using brachial artery flow-mediated dilation via high resolution ultrasonography. Endothelium-independent dilation will be measured using brachial artery dilation to sublingual nitroglycerin. Arterial stiffness and wave reflection will measured using applanation tonometry.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women with non-obstructive coronary artery disease documented within the past 5 years by coronary angiogram as no coronary arteries with stenosis greater than 50% lesions\n* age 18 to 89 years\n* able to complete maximal graded exercise test\n\nExclusion Criteria:\n\n* use of tobacco products within the previous six months\n* use of oral contraceptives or hormone replacement therapy within the prior year\n* pregnancy (positive urine pregnancy test) or lactation\n* history of hepatic disease or infection with hepatitis B, C or HIV'}, 'identificationModule': {'nctId': 'NCT02450318', 'briefTitle': 'Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Acute Vascular Response to Exercise in Women With Nonobstructive Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'IRB201500077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow-paced walking', 'description': 'Subjects will complete 47 minutes of walking at slow pace.', 'interventionNames': ['Other: Slow-paced walking']}], 'interventions': [{'name': 'Slow-paced walking', 'type': 'OTHER', 'description': 'Subjects will walk on a treadmill at a slow pace for 47 minutes', 'armGroupLabels': ['Slow-paced walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Integrative Cardiovasculal Physiology Laboratory', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Demetra Christou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}