Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-03 @ 2:20 AM
Study NCT ID:
NCT06373302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Arterial Disease Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between PAD biomarker levels and walking distance.', 'timeFrame': 'Baseline', 'description': 'The correlation between PAD biomarker levels and walking distance.'}, {'measure': 'Change in PAD biomarker levels following exercise therapy.', 'timeFrame': '6 months up to 2 years', 'description': 'To investigate the change in PAD biomarker levels following exercise therapy.'}, {'measure': 'Change in PAD biomarker levels following endovascular intervention', 'timeFrame': '48 hours', 'description': 'To investigate the change in PAD biomarker levels following endovascular intervention'}], 'secondaryOutcomes': [{'measure': 'To determine whether biomarker levels normalise with improved walking distance.', 'timeFrame': '2 years', 'description': 'Change in biomarker levels in participants with improved walking distance compared to particicpants with static or deteriorating walking distance at 6 months.'}, {'measure': 'To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention.', 'timeFrame': '2 years', 'description': 'Compare the change in biomarkers levels pre and post angioplasty between participants requiring reintervention or occlusion, and those not requiring re-intervention or occlusion.'}, {'measure': 'Levels of biomarkers and (Major Adverse Cardiovascular Events).', 'timeFrame': '2 years', 'description': 'The association between levels of biomarkers and (Major Adverse Cardiovascular Events).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral', 'Arterial', 'Disease', 'Claudication'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression.', 'detailedDescription': 'Several studies have identified markers in the blood (called biomarkers) that are associated with peripheral arterial disease, or clogging up of the blood supply to the leg. There is little understanding however regarding how these respond to intervention, and how they are related to walking distance.\n\nThis study will increase the understanding of the relationship between peripheral arterial disease state and biomarker expression and enable us to work towards the development of new targets for treatment.\n\nParticipants will be invited to undertake questionnaires and dedicated walking tests alongside regular blood tests to check their biomarker levels. These will be undertaken on a regular basis so the investigators can see what happens over time, such as after a surgical procedure, and see if these markers go back towards normal following intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with peripheral arterial disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\> 50 years\n* Symptomatic PAD\n* ABPI \\<0.8 or TBPI \\<0.7\n\nExclusion Criteria:\n\n* Aged \\<50 years\n* Current Malignancy\n* Rheumatological Condition\n* Previous surgical or endovascular intervention for PAD\n* ABPI \\>0.8 or TBPI \\>0.7'}, 'identificationModule': {'nctId': 'NCT06373302', 'acronym': 'PADBIRD', 'briefTitle': 'Peripheral Arterial Disease Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Norfolk and Norwich University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Peripheral Arterial Disease Biomarkers: The Effect of Intervention on Biomarker Levels and Predictors of Restenosis or Deterioration', 'orgStudyIdInfo': {'id': 'IRAS 323948'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exercise Therapy', 'description': 'Patients who are advised by their clinician to undertake exercise therapy as their treatment for peripheral arterial disease'}, {'label': 'Angioplasty', 'description': 'Patients undergoing angioplasty for treatment of peripheral arterial disease, as advised by their clinician.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Phillip Stather', 'role': 'CONTACT', 'email': 'philip.stather@nnuh.nhs.uk', 'phone': '01603 286286'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norfolk and Norwich University Hospitals NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}