Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT02060292
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2013-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2013-11-29', 'studyFirstSubmitQcDate': '2014-02-07', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum Inflammatory Markers', 'timeFrame': 'upto 4 weeks', 'description': 'Fibrinogen, C reacive Protein, IL-6'}], 'primaryOutcomes': [{'measure': 'Fractional Anisotropy', 'timeFrame': 'upto 4 weeks', 'description': 'MRI Diffusion Imaging - measure of cerebral white matter microstructure'}], 'secondaryOutcomes': [{'measure': 'Aortic Pulse Wave Velocity', 'timeFrame': 'upto 4 weeks', 'description': 'Aortic stiffness'}, {'measure': 'MRI Cerebral Perfusion - ASL', 'timeFrame': 'upto 4 weeks'}, {'measure': 'Cerebral Microbleeds', 'timeFrame': 'upto 4 weeks'}, {'measure': 'Cognitive Function', 'timeFrame': 'upto 4 weeks', 'description': 'Montreal Cognitive Assessment'}, {'measure': 'Cardiac MRI', 'timeFrame': 'upto 4 weeks', 'description': 'LV \\& RV Mass'}, {'measure': 'FEV1 % predicted', 'timeFrame': 'upto 4 weeks'}, {'measure': 'Arterial Oxygen Saturation', 'timeFrame': 'upto 4 weeks'}, {'measure': 'Retinal Photography', 'timeFrame': 'upto 4 weeks', 'description': 'Retinal Arterial Narrowing'}, {'measure': 'Micro-albuminuria', 'timeFrame': 'upto 4 weeks', 'description': 'Spot urine albumin sample mg/l (milligram albumin per litre of urine)'}, {'measure': 'Health Status', 'timeFrame': 'upto 4 weeks', 'description': 'COPD Assessment Test (CAT score) 0-40'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Cognitive Function', 'MRI Brain', 'Aortic Stiffness', 'Cerebrovascular disease'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '31923188', 'type': 'DERIVED', 'citation': 'McKay GJ, McCarter RV, Hogg RE, Higbee DH, Bajaj MK, Burrage DR, Ruickbie S, Baker EH, Jones PW, Dodd JW. Simple non-mydriatic retinal photography is feasible and demonstrates retinal microvascular dilation in Chronic Obstructive Pulmonary Disease (COPD). PLoS One. 2020 Jan 10;15(1):e0227175. doi: 10.1371/journal.pone.0227175. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': "Cognitive impairment is a known consequence of cerebral small-vessel disease. Moderate to severe cognitive impairment has been shown in up to 60% of certain individuals with COPD and is likely to profoundly influence an individual's ability to manage their disease.\n\nIn addition to cerebral small vessel damage and cognitive dysfunction, other organs such as the heart, kidneys, and retina are likely to be susceptible to small-vessel damage in COPD. Several large population studies have shown that COPD is a significant independent risk factor for myocardial infarction, with the effect most marked in early, mild disease.\n\nWe propose to compare non-invasive MR brain imaging of white matter microstructure (diffusion tensor), cerebral perfusion (arterial spin labelling) and accumulated cerebral small vessel disease (cerebral microbleeds), in COPD patients to smokers without COPD. In addition we plan to explore mechanisms of cerebral small vessel disease in COPD by looking for associations between arterial stiffness, end organ vascular damage and cognitive function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stable COPD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects must give their signed and dated written informed consent\n2. Subjects must be aged \\>40 and ≤ 85\n3. Subjects with a smoking history \\> 10 pack years.\n4. COPD group: Subjects with a FEV/FVC \\<70%\n\nExclusion Criteria:\n\n1. Resting oxygen saturations \\<92% on room air.\n2. Long term oxygen therapy\n3. Recent exacerbation of COPD (4 weeks)\n4. Ischaemic heart disease\n5. Cerebrovascular disease\n6. Uncontrolled hypertension\n7. Diabetes mellitus\n8. Hepatic failure\n9. Neurological disease\n10. Non-cured tumours\n11. Obstructive sleep apnoea\n12. Current of past alcohol/drug abuse\n13. Known history of dementia\n14. Visual or hearing impairment that precludes neuropsychological assessment\n15. Neuropsychological tests undertaken outside the study\n16. Pregnant women or women who are lactating\n17. Known alpha 1 anti-trypsin deficiency as a cause of their COPD\n18. History of psychiatric disorders, or other conditions that will impact on the validity of their consent or interfere with compliance to perform study procedures.\n19. Contra indication to MRI scanning -'}, 'identificationModule': {'nctId': 'NCT02060292', 'acronym': 'NOVASC COPD', 'briefTitle': 'Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'North Bristol NHS Trust'}, 'officialTitle': 'Novel Vascular Manifestations of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '3251'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD', 'description': 'Stable, Non hypoxaemic, without history of vascular disease'}, {'label': 'Healthy smokers', 'description': 'Age matched, smokers without COPD'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BS10 5NB', 'city': 'Bristol', 'state': 'Avon', 'country': 'United Kingdom', 'facility': 'North Bristol NHS Trust', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}], 'overallOfficials': [{'name': 'James W Dodd, MB ChB PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bristol'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North Bristol NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}