Compliance With The European Society Of Cardiology Prevention Guidelines In Patients at High Cardiovascular Disease Risk

An observational study of Hypertension and Diabetes, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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 Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertension, Diabetes, Dyslipidemias
How many people: 50 participants
Where: No sites listed yet
Study dates: 15 Apr 2018to 15 Sep 2019
How long will I take part?: 1 Year
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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)

Who cannot join

Patients living outside defined geographical area (Assiut Governorate)

Trial locations and contacts

No sites are listed yet.

Hossam Elaraby contact

01223971327

Hosam_hasan@hotmail.com

Khaled Elmaghraby contact

01002580844

Kh_elmaghraby@yahoo.com

About this study

Official title: 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

Read the detailed description

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

Conditions: Hypertension, Diabetes, Dyslipidemias
Medical subject headings: Hypertension, Diabetes Mellitus, Dyslipidemias

What is being measured

The primary outcome is the main question the study is designed to answer.

the incidence of Cardiovascular disease
occurrence of any cardiovascular affection
Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201815 Sep 2019

First posted30 Mar 2018
Study start15 Apr 2018 (estimated)
Primary completion15 Mar 2019 (estimated)
Study completion15 Sep 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Assiut UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 50 participants (estimated)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT03483155
Sponsor's protocol ID: CESC
Status last verified: Mar 2018
First submitted: 12 Mar 2018
Last updated: 30 Mar 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 9347267
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.
PubMed 22698795
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.
PubMed 27222591
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.
PubMed 11259143
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.
PubMed 11293642
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.
PubMed 12590902
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.
PubMed 19287307
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.
PubMed 20577089
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.
PubMed 19286092
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.
PubMed 25899410
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.
PubMed 25670820
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.
PubMed 26427624
Syntax score calculator. syntax working group. 5-19-2009. Ref Type: Electronic Citation

Want to know more?

Hossam Elaraby

01223971327

Hosam_hasan@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Compliance With The European Society Of Cardiology Prevention Guidelines In Patients at High Cardiovascular Disease Risk in Assiut University
ClinicalTrials.gov ID: NCT03483155
Acronym / sponsor ID: CESC
Conditions: Hypertension, Diabetes, Dyslipidemias
Study type: Observational
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Assiut UniversityUniversity, hospital or other
Study start: 15 Apr 2018 (estimated)
Primary completion: 15 Mar 2019 (estimated)
Study completion: 15 Sep 2019 (estimated)
First posted: 30 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Target follow-up: 1 Year

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

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)

Key exclusion criteria (1 listed)

Patients living outside defined geographical area (Assiut Governorate)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

the incidence of Cardiovascular disease
Time frame: 18 months
occurrence of any cardiovascular affection

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
Background: PubMed 9347267EUROASPIRE. 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.
Background: PubMed 22698795Perk 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.
Background: PubMed 27222591Piepoli 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.
Background: PubMed 11259143EUROASPIRE 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.
Background: PubMed 11293642EUROASPIRE 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.
Background: PubMed 12590902De 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.
Background: PubMed 19287307Kotseva 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.
Background: PubMed 20577089Kotseva 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.
Background: PubMed 19286092Kotseva 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.
Background: PubMed 25899410Kotseva 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.
Background: PubMed 25670820Gyberg 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.
Background: PubMed 26427624Gyberg 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hossam Elaraby contact

01223971327

Hosam_hasan@hotmail.com

Khaled Elmaghraby contact

01002580844

Kh_elmaghraby@yahoo.com

Nouran Galal principal investigator

AssiutUniversity

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension and Diabetes, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hossam Elaraby (01223971327, Hosam_hasan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the incidence of Cardiovascular disease (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03483155, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.