Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 7:37 PM
Study NCT ID:
NCT01353612
Status:
COMPLETED
Last Update Posted:
2020-02-24
First Post:
2011-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'samples stored for potential correlation with imaging and cardiovascular outcomes endpoints in subset of patients (optional)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1626}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-20', 'studyFirstSubmitDate': '2011-05-12', 'studyFirstSubmitQcDate': '2011-05-12', 'lastUpdatePostDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'co-primary outcome measure - Nominal change from baseline in percent atheroma volume', 'timeFrame': '2 years', 'description': 'intravascular ultrasound measure'}, {'measure': 'co-primary outcome measure - nominal change from baseline in carotid IMT', 'timeFrame': '2 years', 'description': '2D B-mode carotid ultrasound measure'}], 'secondaryOutcomes': [{'measure': 'cardiovascular morbidity and mortality', 'timeFrame': '5 years', 'description': 'as adjudicated by a Clinical Endpoint Committee'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.canadianimagingnetwork.org/', 'label': 'Canadian Atherosclerosis Imaging Network (CAIN) - "Hearts and Minds"'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center imaging study expecting to enroll approximately 1350 patients scheduled for clinically-indicated coronary angiography. Following informed consent, patient will undergo baseline coronary intravascular ultrasound (IVUS) imaging and non-invasive ultrasound imaging of their carotid arteries. Following a 2-year follow-up period, patients will undergo repeat coronary IVUS and standard invasive coronary angiography as well as carotid ultrasound examination.\n\nAdditionally, patients will be contacted by phone on an annual basis for 5 years to collect cardiovascular and cerebrovascular clinical endpoints. Evaluations of plaque burden will be made using invasive and non invasive imaging tools in order to assess correlations between vascular beds, imaging technologies and main cardiovascular events.', 'detailedDescription': 'CTA and PET Substudy:\n\nA subset of patients enrolled into the main CAIN3 study will undergo a CTA. At sites where both CTA and PET imaging modalities exist, patients will be asked to undergo both tests. The CTA and PET scans can be done separately on 2 imaging beds on different days or performed on the same imaging bed, resulting in a combined CTA and PET scan being done in one scheduled visit. All imaging will be done within 90 days after the follow up IVUS.\n\nThe choice of radiotracer used (NaF or FDG) for PET imaging will be dependent upon site and availability on the day of the scan. A total of 120 patients will be enrolled in this substudy with approximately 50-60 undergoing CTA and PET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with clinical indication for coronary angiography', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients over the age of 18 years.\n* Patients scheduled for clinically indicated coronary angiography and possible ad hoc percutaneous coronary intervention (PCI) will be evaluated before their scheduled procedure.\n* Written informed consent (approved by the Institutional Review Board \\[IRB\\]/Independent Ethics Committee \\[IEC\\]) obtained prior to any study specific procedures.\n* Patients considered to be stable at enrollment (at the discretion of the investigator) are eligible provided they meet all other entry criteria.\n* Angiogram meeting qualifying criteria\n\nExclusion Criteria:\n\n* Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for \\>12 months) who refuse to undergo a urine or serum pregnancy test immediately prior to baseline and repeat imaging evaluations The urine or serum pregnancy test must be negative prior to imaging evaluations.\n* Previous coronary artery bypass graft (CABG) surgery or probable need for CABG in the next 24 months.\n* Patients who have symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class III or IV) at baseline.\n* Patients with clinically significant valvular heart disease likely to require surgical repair or replacement during the treatment period of the study\n* Any clinically significant medical condition or presence of any laboratory abnormality that is considered by the investigator to be clinically important and could interfere with the conduct of the study.\n* The presence of severe liver disease as defined by the presence of cirrhosis, chronic active hepatitis, or chronic jaundice with hyperbilirubinemia,\n* Patients with eGFR \\< 45 ml/min prior to baseline imaging procedures, or with nephrotic syndrome\n* Patients with a life expectancy less than 2 years.\n* History of malignancy (except for curatively treated basal cell or squamous cell carcinoma of the skin) during the 3 years prior to the screening.\n* Unable or unwilling to comply with protocol requirements, or deemed by the investigator to be unfit for the study.'}, 'identificationModule': {'nctId': 'NCT01353612', 'briefTitle': 'Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Atherosclerosis Imaging Network'}, 'officialTitle': 'Correlation Between Coronary and Carotid Atherosclerotic Disease (CAD) and Links With Clinical Outcomes', 'orgStudyIdInfo': {'id': 'CAIN-003'}}, 'contactsLocationsModule': {'locations': [{'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6L 5X8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Foothills Medical Centre'}, {'zip': 'V3L 3W4', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Royal Columbian Hospital', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Interventional Cardiology Research, St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 4R2', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Victoria Heart Institute Foundation', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'John Health Science Center', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 3A7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth II - Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'N1R 6V6', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cambridge Cardiac Care', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster Clinic Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N2M 1B2', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': "St-Mary's Hospital", 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'N2M 5N4', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'KMH Cardiology & Diagnostics Centre', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'N6G 2V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Center', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L5K 2L3', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'KMH Cardiology & Diagnostics Centre', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'L3Y 2R2', 'city': 'Newmarket', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Southlake Regional Health Center', 'geoPoint': {'lat': 44.05011, 'lon': -79.46631}}, {'zip': 'L1J 2J9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Heart Care Research', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'K1Y 4W7', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Ottawa Heart Institute', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M1E 5E9', 'city': 'Scarborough Village', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Scarborough Cardiology Research', 'geoPoint': {'lat': 43.73899, 'lon': -79.22124}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Science Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G7H 5H6', 'city': 'Chicoutimi', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Complexe Hospitalier de la Sagamie', 'geoPoint': {'lat': 48.41963, 'lon': -71.06369}}, {'zip': 'J1H 5N4', 'city': 'Fleurimont', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUS-Hopital Fleurimont', 'geoPoint': {'lat': 45.40842, 'lon': -71.83796}}, {'zip': 'J8Y 6S9', 'city': 'Gatineau', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CSSS-Hopital de Gatineau, secteur Hull', 'geoPoint': {'lat': 45.47723, 'lon': -75.70164}}, {'zip': 'J4V 2G8', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Viacar Recherche Clinique', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H7M 3L9', 'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CSSS de Laval', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'J4M 2X1', 'city': 'Longueuil', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Pierre Boucher', 'geoPoint': {'lat': 45.5152, 'lon': -73.46818}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUM Hopital-Hôtel-Dieu', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CUSM Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4J 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hopital Sacré-Cœur de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut Universitaire de Cardiologie et de Pneumologie de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J6E 6J2', 'city': 'Saint-Charles-Borromée', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Régional de Lanaudière', 'geoPoint': {'lat': 46.05007, 'lon': -73.46586}}, {'zip': 'G5Y 4T8', 'city': 'Saint-Georges', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de santé et des services sociaux de Beauce', 'geoPoint': {'lat': 46.11353, 'lon': -70.66526}}, {'zip': 'J7Z 5T3', 'city': 'Saint-Jérôme', 'state': 'Quebec', 'country': 'Canada', 'facility': 'St-Jerome Medical Research Inc.', 'geoPoint': {'lat': 45.78036, 'lon': -74.00365}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Quebec', 'country': 'Canada', 'facility': "St. Michael's Hospital"}, {'zip': 'G8Z 3R9', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHRTR de Trois-Rivières', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'J9P 3Y1', 'city': "Val-d'Or", 'state': 'Quebec', 'country': 'Canada', 'facility': "CSSS Vallée de l'Or", 'geoPoint': {'lat': 48.0974, 'lon': -77.79737}}, {'zip': 'S7N OW8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Jean-Claude Tardif, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Montreal Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Atherosclerosis Imaging Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}