Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-22 @ 5:30 AM
Study NCT ID:
NCT03921905
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2019-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 713}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-28', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The incidence of Acute coronary syndrome', 'timeFrame': '12 months'}, {'measure': 'The incidence of Stroke', 'timeFrame': '12 months'}, {'measure': 'The incidence of Transient ischemic attack', 'timeFrame': '12 months'}, {'measure': 'The incidence of Heart Failure', 'timeFrame': '12 months'}, {'measure': 'The incidence of Atrial fibrillation or Flutter', 'timeFrame': '12 months'}, {'measure': 'The incidence of Coronary artery revascularization', 'timeFrame': '12 months'}, {'measure': 'The incidence of Hospitalization for worsening of PAD', 'timeFrame': '12 months'}, {'measure': 'The incidence of Limb peripheral artery revascularization', 'timeFrame': '12 months'}, {'measure': 'The incidence of Lower limb amputation for arterial vascular disease', 'timeFrame': '12 months'}, {'measure': 'The incidence of Major bleeding (bleeding leading to hospitalization, bleeding requiring surgical procedures to manage the bleeding, bleeding requiring blood trabsfusion)', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD®', 'timeFrame': '1 day', 'description': 'The prevalence of PAD will be diagnosed measuring the ankle-brachial-index (ABI) determined by dividing the higher systolic pressure measured at the ankle of both legs by the brachial arterial systolic pressure. An ABI value \\<=0.9 is an indicator of the presence of PAD indicating athero-occlusive arterial disease while \\>1.3/1.4 indicates an incompressible ankle arteries. The ABI measurement will be performed using the automatic device MESI ABPI MD.'}], 'secondaryOutcomes': [{'measure': 'To measure the Blood pressure (mmHg)', 'timeFrame': '1 day'}, {'measure': 'To measure the Heart rate (bpm)', 'timeFrame': '1 day'}, {'measure': 'To measure the Weight (kg)', 'timeFrame': '1 day'}, {'measure': 'To measure the Height (cm)', 'timeFrame': '1 day'}, {'measure': 'To measure the Body mass index (Kg/m2)', 'timeFrame': '1 day'}, {'measure': 'To measure the Ankle Brachial Index (ABI) Value', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Limb peripheral artery revascularization', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Limb or foot amputation for arterial vascular disease', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Clinical presentation of lower extremity disease', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Aortic aneurysm', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Carotid artery stenosis', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Heart Failure', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Atrial Fibrillation or Flutter', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Hypertension', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Dyslipidemia', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Chronic Kidney disease', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Stroke', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Transient ischemic attack', 'timeFrame': '1 day'}, {'measure': 'Clinical History of Bleeding', 'timeFrame': '1 day'}, {'measure': 'Clinical History of cancer', 'timeFrame': '1 day'}, {'measure': 'The dietary habits', 'timeFrame': '1 day', 'description': 'The Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered'}, {'measure': 'Physical activity', 'timeFrame': '1 day', 'description': 'The Physical activity Questionnaire (BRFSS 2 items) will be administered'}, {'measure': 'Total cholesterol (mg/dL)', 'timeFrame': '1 day'}, {'measure': 'LDL cholesterol (mg/dL)', 'timeFrame': '1 day'}, {'measure': 'HDL cholesterol (mg/dL)', 'timeFrame': '1 day'}, {'measure': 'Triglycerides (mg/dL)', 'timeFrame': '1 day'}, {'measure': 'Glycemia (mg/dL)', 'timeFrame': '1 day'}, {'measure': 'Glycated hemoglobin (only for patients with diabetes mellitus) (%)', 'timeFrame': '1 day'}, {'measure': 'Creatinine (mg/dL)', 'timeFrame': '1 day'}, {'measure': 'Alanine aminotransferase (ALT) (U/L)', 'timeFrame': '1 day'}, {'measure': 'Aspartate aminotransferase (AST) (U/L)', 'timeFrame': '1 day'}, {'measure': 'Hemoglobin (g/dL)', 'timeFrame': '1 day'}, {'measure': 'Platelet count (x 103μL)', 'timeFrame': '1 day'}, {'measure': 'Hematocrit (%)', 'timeFrame': '1 day'}, {'measure': 'Red blood cells (x10^3 ml)', 'timeFrame': '1 day'}, {'measure': 'White blood cells (x10^3 ml)', 'timeFrame': '1 day'}, {'measure': 'Marital status', 'timeFrame': '1 day'}, {'measure': 'Education Status', 'timeFrame': '1 day'}, {'measure': 'Employment status', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peripheral Artery Disease', 'Coronary Artery Disease', 'General Practice', 'Ankle-brachial index (ABI)'], 'conditions': ['Peripheral Artery Disease']}, 'referencesModule': {'references': [{'pmid': '39347889', 'type': 'RESULT', 'citation': 'Baviera M, Foresta A, Fernandez LO, Torrigiani G, Tettamanti M, Roncaglioni MC, Cimminiello C; PAD, C. A. D. Study Group. Peripheral artery disease in patients with stable coronary artery disease in general practice: results from an Italian nationwide study-PAD & CAD study. Intern Emerg Med. 2025 Jan;20(1):159-169. doi: 10.1007/s11739-024-03771-9. Epub 2024 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while \\>1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.', 'detailedDescription': "National, multicentre, observational, prospective study. This study will be carried out with the collaboration with Study Center for Primary Care and with the Italian Society of Angiology and Vascular Medicine (SIAPAV).\n\nThe eligible patients with stable CAD will be called by General Practitioners (GPs).\n\nFor all patients who agree to participate in the study and sign the consent, two visits will be done at baseline and after 12 months.\n\nAt baseline will be collected information on socio-demographic and anthropometric data, blood pressure, heart rate, CV risk factors, medical history, lifestyle habits, PAD stage (for patient with abnormal ABI) and pharmacological therapy. ABI measurement will be done using an automatic simple device. In case of abnormal ABI value, a SIAPAV vascular specialist, at GP's office, will confirm it using the standard manual continuous wave (CW) Doppler.\n\nAt follow-up visit the following information will be collected the: referral to vascular specialist (if requested, at discretion of the GP), relevant change in pharmacological therapy, major CV events and progression of PAD, limb and coronary artery revascularizations, amputations, major bleeding, and death."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of stable CAD in charge of GPs, giving the consent to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes with a diagnosis of stable CAD as follows: acute myocardial infarction or percutaneous coronary revascularization or coronary artery bypass graft surgery occured at least 12 months before entering the study or chronic stable angina.\n\nExclusion Criteria:\n\n* Mental illness limiting the capacity of self-care or any condition limiting seriously the life expectancy less than 12 months.'}, 'identificationModule': {'nctId': 'NCT03921905', 'acronym': 'PAD&CAD', 'briefTitle': 'Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.', 'organization': {'class': 'OTHER', 'fullName': 'Mario Negri Institute for Pharmacological Research'}, 'officialTitle': 'Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.', 'orgStudyIdInfo': {'id': 'IRFMN-7825'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with CAD', 'description': 'In this study will be included patients with stable CAD', 'interventionNames': ['Diagnostic Test: ABI measurement']}], 'interventions': [{'name': 'ABI measurement', 'type': 'DIAGNOSTIC_TEST', 'description': 'ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD', 'armGroupLabels': ['Patients with CAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16165', 'city': 'Genova', 'state': 'GE', 'country': 'Italy', 'facility': 'MEDICOOP Genova', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20154', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Cooperativa Medici Milano Centro', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '89134', 'city': 'Reggio Calabria', 'state': 'RC', 'country': 'Italy', 'facility': 'MEDICOOP S. Agata', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '00137', 'city': 'Rome', 'state': 'RM', 'country': 'Italy', 'facility': 'ROMAMED Service', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Marta Baviera, PharmD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istituto Di Ricerche Farmacologiche Mario Negri'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bayer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}