Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
Study NCT ID:
NCT04291157
Status:
UNKNOWN
Last Update Posted:
2020-03-02
First Post:
2020-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000096442', 'term': 'Genetic Risk Score'}], 'ancestors': [{'id': 'D020022', 'term': 'Genetic Predisposition to Disease'}, {'id': 'D004198', 'term': 'Disease Susceptibility'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Large simple randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-27', 'studyFirstSubmitDate': '2020-02-19', 'studyFirstSubmitQcDate': '2020-02-27', 'lastUpdatePostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total 10 year cardiovascular disease (CVD) risk', 'timeFrame': '12 months', 'description': 'SCORE (Systematic COronary Risk Evaluation), estimates fatal cardiovascular disease events over a ten-year period in %.\n\nEmploys categories of 1) low (calculated SCORE \\<1%) 2) moderate-risk (calculated SCORE1% to \\<5%), 39 ) high-risk (calculated SCORE5% to \\<10%) and 3) very-high-risk (calculated SCORE ≥10%).\n\nConroy RM , Pyorala K, Fitzgerald AP et al. Estimation of ten-year risk of fatal cardiovascular disease in Europe: the SCORE project. Eur H J2003;24:987-1003.'}], 'secondaryOutcomes': [{'measure': 'Treatment initiation (first prescription) or dose escalation (new prescription with a higher dose) of CVD preventive pharmacotherapy', 'timeFrame': '12 months', 'description': 'New prescription or a dose escalation of any anti-hypertensive, lipid lowering, anti-platelet or anti-smoking medicinal product.'}, {'measure': 'Adherence to CVD prevention recommendations', 'timeFrame': '12 months', 'description': 'Adherence to CVD prevention recommendations - proportion of patients adhering to lifestyle advice as recorded by GP.'}, {'measure': 'Systolic blood pressure', 'timeFrame': '12 months', 'description': 'Sitting systolic blood pressure measured by automated device at GP office, mmHg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '12 months', 'description': 'Sitting diastolic blood pressure measured by automated device at GP office, mmHg'}, {'measure': 'Total cholesterol', 'timeFrame': '12 months', 'description': 'mmol/L'}, {'measure': 'LDL cholesterol', 'timeFrame': '12 months', 'description': 'mmol/L'}, {'measure': 'BMI', 'timeFrame': '12 months', 'description': 'Body mass index, height (m) and weight (kg) combined (kg/m2)'}, {'measure': 'Waist circumference', 'timeFrame': '12 months', 'description': 'cm, measured at GP office'}, {'measure': 'Smoking status', 'timeFrame': '12 months', 'description': 'Self-reported smoking status as recorded at GP office'}, {'measure': 'Physical activity', 'timeFrame': '12 months', 'description': 'Self-reported physical activity, min/week, as recorded at GP office'}, {'measure': 'Satisfaction of gene donors with intervention', 'timeFrame': '12 months', 'description': 'Satisfaction of gene donors with intervention - descriptive questionnaire, analysed qualitatively'}, {'measure': 'Satisfaction of GPs with intervention', 'timeFrame': '12 months', 'description': 'Satisfaction of GPs with intervention - descriptive questionnaire, analysed qualitatively'}, {'measure': 'Cost-effectiveness of intervention', 'timeFrame': '12 months, modelled over lifetime', 'description': 'Incremental cost-effectiveness ratio (EUR/QALY): cost of intervention combined in an economic model with lifetime benefit (number of quality adjusted life years modelled based on change in total CVD risk, measured as primary endpoint).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polygenic risk score'], 'conditions': ['Cardiovascular Diseases', 'Primary Prevention']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://sisu.ut.ee/pmkliinilisedjuhtprojektid', 'label': 'Study general information and contacts'}]}, 'descriptionModule': {'briefSummary': 'A polygenic risk score (PRS) will be developed and implemented into the primary care digital work-flow.\n\n1000 study subjects with no known cardiovascular disease, diabetes or statin treatment and with high PRS (men of 30-65, women of 40-70 years of age) will be recruited from amongst the gene donors of Estonian Biobank (Estonian Genome Center at the University of Tartu).\n\nSubjects will be randomised to proactive primary preventive intervention incorporating provision of PRS information or usual care (opportunistic preventive strategy).\n\nSubjects in intervention group will be actively contacted and invited to a general practitioner (GP) based prevention intervention of total cardiovascular risk scoring and guideline recommended preventive measures.\n\nSubjects in control group will be observed for 12 month and then invited to a GP visit and provided the same information and advice as the intervention group.\n\nThe impact of PRS on total 10 year cardiovascular disease (CVD) risk scoring will be assessed, the change in total 10 year CVD risk during the intervention will be measured and the difference in total 10 year CVD risk between the groups at month 12 will be reported. Satisfaction of subjects and GPs with the intervention will also be assessed as well as cost-effectiveness of the intervention.', 'detailedDescription': 'A polygenic risk score (PRS) will be developed and implemented into the primary care digital work-flow.\n\n1000 study subjects with no known cardiovascular disease, diabetes or statin treatment and with high PRS (men of 30-65, women of 40-70 years of age) will be recruited from amongst the gene donors of Estonian Biobank (Estonian Genome Center at the University of Tartu).\n\nSubjects will be randomised to proactive primary preventive intervention incorporating provision of PRS information or usual care (opportunistic preventive strategy).\n\nSubjects in intervention group will be actively contacted and invited to a GP based prevention intervention of total cardiovascular risk scoring and guideline recommended preventive measures.\n\nSubjects in control group will be observed for 12 month and then invited to a GP visit and provided the same information and advice as the intervention group.\n\nThe impact of PRS on total 10 year CVD risk scoring will be assessed, the change in total 10 year CVD risk during the intervention will be measured and the difference in total 10 year CVD risk between the groups at month 12 will be reported. Satisfaction of subjects and GPs with the intervention will also be assessed as well as cost-effectiveness of the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male 30-65 years or female 40-70 years\n* No history of ischemic heart disease, stroke, TIA or PAD in electronic health record\n* No cholesterol lowering treatment\n* No history of diabetes\n* High PRS of CVD\n* No physical or mental conditions precluding informed consent or participation\n\nExclusion Criteria:\n\n* History of ischemic heart disease, stroke, transitory ischemic attack (TIA) or peripheral artery disease (PAD) in electronic health record\n* Cholesterol lowering treatment\n* History of diabetes\n* No consent to participate'}, 'identificationModule': {'nctId': 'NCT04291157', 'acronym': 'EstPerMedCV', 'briefTitle': 'Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk', 'organization': {'class': 'OTHER', 'fullName': 'University of Tartu'}, 'officialTitle': 'Implementability and Health Impact of Proactive Cardiovascular Prevention Strategy in Subjects With High Genetic Risk: a Randomized Pilot Study', 'orgStudyIdInfo': {'id': 'EstPerMed CV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Proactive CVD prevention', 'description': 'Proactive invitation to total CVD risk estimation incorporating the PRS and provision of guideline based preventive interventions.', 'interventionNames': ['Other: CVD risk estimation incorporating the PRS and guideline based preventive interventions.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Usual GP care (opportunistic CVD risk estimation and prevention upon usual GP contacts).', 'interventionNames': ['Other: Standard GP care']}], 'interventions': [{'name': 'CVD risk estimation incorporating the PRS and guideline based preventive interventions.', 'type': 'OTHER', 'description': 'Total CVD risk estimation using SCORE plus PRS and European Society of Cardiology (ESC) CVD prevention guideline based interventions.', 'armGroupLabels': ['Proactive CVD prevention']}, {'name': 'Standard GP care', 'type': 'OTHER', 'description': 'Usual GP care (opportunistic CVD prevention)', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13419', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'North Estonia Medical Centre', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '50406', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}], 'overallOfficials': [{'name': 'Margus Viigimaa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Tartu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alar Irs', 'class': 'OTHER'}, 'collaborators': [{'name': 'North Estonia Regional Hospital', 'class': 'UNKNOWN'}, {'name': 'Tartu University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Teaching physician in cardiology', 'investigatorFullName': 'Alar Irs', 'investigatorAffiliation': 'University of Tartu'}}}}