NCT03483155

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

11 months

First QC Date

March 12, 2018

Last Update Submit

March 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • the incidence of Cardiovascular disease

    occurrence of any cardiovascular affection

    18 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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)

You may not qualify if:

  • Patients living outside defined geographical area (Assiut Governorate)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 9347267BACKGROUND
  • 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.

    PMID: 22698795BACKGROUND
  • 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.

    PMID: 27222591BACKGROUND
  • 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.

    PMID: 11259143BACKGROUND
  • 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.

    PMID: 11293642BACKGROUND
  • 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.

    PMID: 12590902BACKGROUND
  • 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.

    PMID: 19287307BACKGROUND
  • 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.

    PMID: 20577089BACKGROUND
  • 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.

    PMID: 19286092BACKGROUND
  • 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.

    PMID: 25899410BACKGROUND
  • 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.

    PMID: 25670820BACKGROUND
  • 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.

    PMID: 26427624BACKGROUND
  • Syntax score calculator. syntax working group. 5-19-2009. Ref Type: Electronic Citation

    BACKGROUND

MeSH Terms

Conditions

HypertensionDiabetes MellitusDyslipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Study Officials

  • Nouran Galal

    AssiutUniversity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Compliance With The European Society Of Cardiology Prevention Guidelines In Patients at High Cardiovascular Disease Risk in Assiut University

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 30, 2018

Study Start

April 15, 2018

Primary Completion

March 15, 2019

Study Completion

September 15, 2019

Last Updated

March 30, 2018

Record last verified: 2018-03