- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03483155
Compliance With The European Society Of Cardiology Prevention Guidelines In Patients at High Cardiovascular Disease Risk
23. mars 2018 oppdatert av: Noran Mohamed, Assiut University
Compliance With The European Society Of Cardiology Prevention Guidelines In Patients at High Cardiovascular Disease Risk in Assiut University
Patients with coronary or other atherosclerotic cardiovascular disease and those at high risk of developing cardiovascular disease have been defined as the highest clinical priorities for prevention
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
Cardiovascular disease prevention programs are designed to reduce patients' morbidity and mortality.the
European society of cardiology with other partner societies has engaged in a comprehensive programme of cardiovascular disease prevention in clinical practice aimed to improve practice of preventive cardiology by encouraging the development of national guidance on cardiovascular disease prevention
Studietype
Observasjonsmessig
Registrering (Forventet)
50
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Patients will be identified from hospital registries and general practice medical notes and will be interviewed between 6 months and 2 years after the date of recruiting event or procedure.
Beskrivelse
Inclusion Criteria:
- Patients having signed an informed Consent Patients aged from 18 to 80 years old at the time of identification At least six and at most 24 months elapsed between the index event (the recruiting diagnostic or treatment criteria below) and the date of interview Patients meeting the recruiting diagnostic or treatment criteria: High CVD risk patients: patients free of CVD, who have been prescribed one or more of the following treatments: blood pressure and/or lipid-lowering and/or glucose lowering (diet and/or oral hypoglycaemic agents)
Exclusion Criteria:
- Patients living outside defined geographical area (Assiut Governorate)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
the incidence of Cardiovascular disease
Tidsramme: 18 months
|
occurrence of any cardiovascular affection
|
18 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Nouran Galal, AssiutUniversity
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- EUROASPIRE I and II Group; European Action on Secondary Prevention by Intervention to Reduce Events. Clinical reality of coronary prevention guidelines: a comparison of EUROASPIRE I and II in nine countries. EUROASPIRE I and II Group. European Action on Secondary Prevention by Intervention to Reduce Events. Lancet. 2001 Mar 31;357(9261):995-1001. doi: 10.1016/s0140-6736(00)04235-5.
- Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala K, Keil U; EUROASPIRE Study Group. Cardiovascular prevention guidelines in daily practice: a comparison of EUROASPIRE I, II, and III surveys in eight European countries. Lancet. 2009 Mar 14;373(9667):929-40. doi: 10.1016/S0140-6736(09)60330-5.
- Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala K, Keil U; EUROASPIRE Study Group. EUROASPIRE III: a survey on the lifestyle, risk factors and use of cardioprotective drug therapies in coronary patients from 22 European countries. Eur J Cardiovasc Prev Rehabil. 2009 Apr;16(2):121-37. doi: 10.1097/HJR.0b013e3283294b1d.
- Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.
- EUROASPIRE. A European Society of Cardiology survey of secondary prevention of coronary heart disease: principal results. EUROASPIRE Study Group. European Action on Secondary Prevention through Intervention to Reduce Events. Eur Heart J. 1997 Oct;18(10):1569-82. doi: 10.1093/oxfordjournals.eurheartj.a015136. Erratum In: Eur Heart J 1998 Feb;19(2):356-7.
- Perk J, De Backer G, Gohlke H, Graham I, Reiner Z, Verschuren WM, Albus C, Benlian P, Boysen G, Cifkova R, Deaton C, Ebrahim S, Fisher M, Germano G, Hobbs R, Hoes A, Karadeniz S, Mezzani A, Prescott E, Ryden L, Scherer M, Syvanne M, Scholte Op Reimer WJ, Vrints C, Wood D, Zamorano JL, Zannad F; Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice; European Association for Cardiovascular Prevention and Rehabilitation. European Guidelines on cardiovascular disease prevention in clinical practice (version 2012): The Fifth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of nine societies and by invited experts). Atherosclerosis. 2012 Jul;223(1):1-68. doi: 10.1016/j.atherosclerosis.2012.05.007. Epub 2012 May 14. No abstract available.
- EUROASPIRE II Study Group. Lifestyle and risk factor management and use of drug therapies in coronary patients from 15 countries; principal results from EUROASPIRE II Euro Heart Survey Programme. Eur Heart J. 2001 Apr;22(7):554-72. doi: 10.1053/euhj.2001.2610.
- De Sutter J, De Bacquer D, Kotseva K, Sans S, Pyorala K, Wood D, De Backer G; EUROpean Action on Secondary Prevention through Intervention to Reduce Events II study group. Screening of family members of patients with premature coronary heart disease; results from the EUROASPIRE II family survey. Eur Heart J. 2003 Feb;24(3):249-57. doi: 10.1016/s0195-668x(02)00386-x.
- Kotseva K, Wood D, De Backer G, De Bacquer D, Pyorala K, Reiner Z, Keil U; EUROASPIRE Study Group. EUROASPIRE III. Management of cardiovascular risk factors in asymptomatic high-risk patients in general practice: cross-sectional survey in 12 European countries. Eur J Cardiovasc Prev Rehabil. 2010 Oct;17(5):530-40. doi: 10.1097/HJR.0b013e3283383f30.
- Kotseva K, Ryden L, De Backer G, De Bacquer D, Wood D. EURObservational research programme: EUROASPIRE. Eur Heart J. 2015 Apr 21;36(16):950-1. doi: 10.1093/eurheartj/ehv047. No abstract available.
- Gyberg V, De Bacquer D, Kotseva K, De Backer G, Schnell O, Sundvall J, Tuomilehto J, Wood D, Ryden L; EUROASPIRE IV Investigators. Screening for dysglycaemia in patients with coronary artery disease as reflected by fasting glucose, oral glucose tolerance test, and HbA1c: a report from EUROASPIRE IV--a survey from the European Society of Cardiology. Eur Heart J. 2015 May 14;36(19):1171-7. doi: 10.1093/eurheartj/ehv008. Epub 2015 Feb 9.
- Gyberg V, De Bacquer D, De Backer G, Jennings C, Kotseva K, Mellbin L, Schnell O, Tuomilehto J, Wood D, Ryden L, Amouyel P, Bruthans J, Conde AC, Cifkova R, Deckers JW, De Sutter J, Dilic M, Dolzhenko M, Erglis A, Fras Z, Gaita D, Gotcheva N, Goudevenos J, Heuschmann P, Laucevicius A, Lehto S, Lovic D, Milicic D, Moore D, Nicolaides E, Oganov R, Pajak A, Pogosova N, Reiner Z, Stagmo M, Stork S, Tokgozoglu L, Vulic D; EUROASPIRE Investigators. Patients with coronary artery disease and diabetes need improved management: a report from the EUROASPIRE IV survey: a registry from the EuroObservational Research Programme of the European Society of Cardiology. Cardiovasc Diabetol. 2015 Oct 1;14:133. doi: 10.1186/s12933-015-0296-y.
- Syntax score calculator. syntax working group. 5-19-2009. Ref Type: Electronic Citation
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
15. april 2018
Primær fullføring (Forventet)
15. mars 2019
Studiet fullført (Forventet)
15. september 2019
Datoer for studieregistrering
Først innsendt
12. mars 2018
Først innsendt som oppfylte QC-kriteriene
23. mars 2018
Først lagt ut (Faktiske)
30. mars 2018
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. mars 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. mars 2018
Sist bekreftet
1. mars 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CESC (Local Ethic Committee for clinical trials)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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