Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT03140605
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Greek Registry - Familial Hypercholesterolaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006938', 'term': 'Hyperlipoproteinemia Type II'}], 'ancestors': [{'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006951', 'term': 'Hyperlipoproteinemias'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the prevalence of Familiar Hypercholesterolaemia in Greece', 'timeFrame': '1 month', 'description': 'patients with FH will be screened and include in Registry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Familial Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '17239976', 'type': 'BACKGROUND', 'citation': 'Kolovou GD, Damaskos DS, Anagnostopoulou KK, Salpea KD, Dritsas A, Giannakopoulou V, Vasiliadis IK, Cokkinos DV. Stress testing response in women heterozygous for familial hypercholesterolemia. Int J Cardiol. 2007 Oct 31;122(1):96-7. doi: 10.1016/j.ijcard.2006.11.046. Epub 2007 Jan 18.'}, {'pmid': '17235114', 'type': 'BACKGROUND', 'citation': 'Kolovou GD, Dedoussis GV, Anagnostopoulou KK, Hatzigeorgiou GCh, Salpea KD, Choumerianou DM, Rammos S, Mikhailidis DP, Cokkinos DV. Management of a patient with a null low-density lipoprotein receptor mutation: a case report. Angiology. 2006 Dec-2007 Jan;57(6):729-32. doi: 10.1177/0003319706294421.'}, {'pmid': '20826022', 'type': 'BACKGROUND', 'citation': 'Kolovou GD, Kostakou PM, Anagnostopoulou KK. Familial hypercholesterolemia and triglyceride metabolism. Int J Cardiol. 2011 Mar 17;147(3):349-58. doi: 10.1016/j.ijcard.2010.08.009. Epub 2010 Sep 9.'}, {'pmid': '26447655', 'type': 'BACKGROUND', 'citation': 'Markousis-Mavrogenis G, Mavrogeni S, Kolovou G. Early coronary artery disease--Usual and unusual suspects. Int J Cardiol. 2016 Jan 1;202:511. doi: 10.1016/j.ijcard.2015.09.050. Epub 2015 Sep 25. No abstract available.'}, {'pmid': '27678429', 'type': 'BACKGROUND', 'citation': 'Beliard S, Millier A, Carreau V, Carrie A, Moulin P, Fredenrich A, Farnier M, Luc G, Rosenbaum D, Toumi M, Bruckert E; French FH Registry group. The very high cardiovascular risk in heterozygous familial hypercholesterolemia: Analysis of 734 French patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1129-1136.e3. doi: 10.1016/j.jacl.2016.06.007. Epub 2016 Jun 27.'}, {'pmid': '27794106', 'type': 'BACKGROUND', 'citation': 'Mundal L, Igland J, Ose L, Holven KB, Veierod MB, Leren TP, Retterstol K. Cardiovascular disease mortality in patients with genetically verified familial hypercholesterolemia in Norway during 1992-2013. Eur J Prev Cardiol. 2017 Jan;24(2):137-144. doi: 10.1177/2047487316676135. Epub 2016 Oct 28.'}, {'pmid': '27939304', 'type': 'BACKGROUND', 'citation': 'EAS Familial Hypercholesterolaemia Studies Collaboration; Vallejo-Vaz AJ, Akram A, Kondapally Seshasai SR, Cole D, Watts GF, Hovingh GK, Kastelein JJ, Mata P, Raal FJ, Santos RD, Soran H, Freiberger T, Abifadel M, Aguilar-Salinas CA, Alnouri F, Alonso R, Al-Rasadi K, Banach M, Bogsrud MP, Bourbon M, Bruckert E, Car J, Ceska R, Corral P, Descamps O, Dieplinger H, Do CT, Durst R, Ezhov MV, Fras Z, Gaita D, Gaspar IM, Genest J, Harada-Shiba M, Jiang L, Kayikcioglu M, Lam CS, Latkovskis G, Laufs U, Liberopoulos E, Lin J, Lin N, Maher V, Majano N, Marais AD, Marz W, Mirrakhimov E, Miserez AR, Mitchenko O, Nawawi H, Nilsson L, Nordestgaard BG, Paragh G, Petrulioniene Z, Pojskic B, Reiner Z, Sahebkar A, Santos LE, Schunkert H, Shehab A, Slimane MN, Stoll M, Su TC, Susekov A, Tilney M, Tomlinson B, Tselepis AD, Vohnout B, Widen E, Yamashita S, Catapano AL, Ray KK. Pooling and expanding registries of familial hypercholesterolaemia to assess gaps in care and improve disease management and outcomes: Rationale and design of the global EAS Familial Hypercholesterolaemia Studies Collaboration. Atheroscler Suppl. 2016 Dec;22:1-32. doi: 10.1016/j.atherosclerosissup.2016.10.001. Epub 2016 Dec 7.'}, {'pmid': '39728301', 'type': 'DERIVED', 'citation': 'Kolovou G, Makrygiannis S, Marvaki C, Pavlatou N, Anagnostopoulou K, Giannakopoulou V, Goumas G, Kalogeropoulos P, Kolovou V, Limberi S, Perrea D, Tzenalis A, Emre Z, Jahaj E, Kasiara Z, Giannakoulis I, Tsolakoglou I, Kadda O, Tsaloukidis N, Koulaxidou R, Marvaki A, Foussas S, Melidonis A, Hoursalas G, Vlachopoulos C, Katsiki N, Milionis H, Liberopoulos E, Bilianou H. Prevalence and Risk Factors for Atherosclerotic Cardiovascular Disease in 7704 Individuals: An Analysis from the Greek Registry for the Prevalence of Familial Hypercholesterolemia (GRegistry-FH). J Cardiovasc Dev Dis. 2024 Dec 23;11(12):411. doi: 10.3390/jcdd11120411.'}]}, 'descriptionModule': {'briefSummary': 'Familial hypercholesterolemia (FH) \\[heterozygous (heFH) or homozygous FH (hoFH)\\] is a common genetic disorder, characterized by elevated plasma low density lipoprotein (LDL) cholesterol concentration leading (if untreated) to cholesterol deposits in the corneas, eyelids and extensor tendons, rapidly progressing vascular disease, and aortic valve disease.', 'detailedDescription': 'In contrast, timely recognition and effective treatment of FH can result in a significant improvement in clinical outcomes. The problem is that that majority of individuals with FH are unaware of their disease, particularly that the disease remains silent for many years. In most countries around the world \\<5% of individuals with FH are identified .\n\nUntil lately the prevalence of heFH was traditionally considered to be \\~ 1:500 individuals , although clinical and genetic studies suggest that heFH affects \\~ 1:200-250 individuals . Thus, the aim of the Hellenic College of Treatment of Atherosclerosis (HCAT) is to 1). Evaluate the prevalence of FH in Greece (FHG-Registry) and 2). To inform population of FH disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sample of citizents on Panhellenic basis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* both genders\n* \\>18 years, \\<80 years\n* door to door enrolment\n* eligible to sign informed consent\n\nExclusion Criteria:\n\n* \\<18 years, \\>80 years\n* deny to sign informed consent'}, 'identificationModule': {'nctId': 'NCT03140605', 'acronym': 'GRegistry-FH', 'briefTitle': 'Greek Registry - Familial Hypercholesterolaemia', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic College of Treatment of Atherosclerosis'}, 'officialTitle': 'Hellenic Registry for Familial Hypercholesterolemia', 'orgStudyIdInfo': {'id': '2017-HPLS-IIS'}}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Genovefa Kolovou, MD', 'role': 'CONTACT'}], 'facility': 'Onassis Cardiology Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Genovefa Kolovou, MD', 'role': 'CONTACT', 'email': 'genovefa@kolovou.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic College of Treatment of Atherosclerosis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist, Head of Hellenic College of Treatment of Atherosclerosis', 'investigatorFullName': 'Genovefa Kolovou, M.D., Ph.D., F.E.S.C., S.F.S.A', 'investigatorAffiliation': 'Hellenic College of Treatment of Atherosclerosis'}}}}