NCT03511885

Brief Summary

EUROASPIRE is a multicentre European study in coronary patients and individuals at high risk of developing cardiovascular disease (CVD), describing their management through lifestyle and use of drug therapies and providing an objective assessment of clinical implementation of current scientific knowledge. Four EUROASPIRE surveys have been carried out by the European Society of Cardiology so far: EUROASPIRE I in 1995-1997 in nine countries, EUROASPIRE II in 1999- 2000 in 15 countries, EUROASPIRE III in 2006-2009 in 22 countries and EUROASPIRE IV in 2012-2015 in 26 countries. The results showed a wide gap between the recommendations and clinical practice with many patients not achieving the lifestyle and medical risk factors goals for CVD prevention. The fifth EUROASPIRE survey is planned for 2016-2018 to determine in hospital coronary patients and apparently healthy individuals in primary care at high risk of developing cardiovascular disease whether the European and national guidelines on cardiovascular disease prevention have been followed and if the practice of preventive cardiology in EUROASPIRE IV has improved by comparison with those centres which took part in EUROASPIRE I, II, III and IV. This survey will also incorporate an assessment of dysglycaemia and kidney function in all patients. The main outcome measures will be the proportions of coronary and high cardiovascular risk patients achieving the lifestyle, risk factor and therapeutic targets for cardiovascular disease prevention. The data collection will be based on a review of patient medical records and a patient interview and examination at least 6 months and at most 3 years after recruiting event. All countries which participated in the first three surveys will be invited to take part in EUROASPIRE V. This fifth survey will give a unique picture of preventive action by cardiologists and primary care physicians looking after patients with coronary disease and individuals at high CVD risk.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,736

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 23, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

April 16, 2018

Last Update Submit

August 13, 2019

Conditions

Keywords

CardiovascularPreventionEUROASPIRE

Outcome Measures

Primary Outcomes (1)

  • Proportions of hospital coronary patients and high risk individuals in primary care achieving European lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention

    The management of risk in terms of lifestyle intervention and the use of drug therapies will be evaluated in relation to the lifestyle and therapeutic goals defined in the national and European guidelines on cardiovascular disease prevention. smoking prevalence BMI in kg/m2 blood pressure in mmHg Total cholesterol in mmol/L LDL-cholesterol in mmol/L HDL-cholesterol in mmol/L glucose in mmol/L HbA1c in % cardioprotective medication by drug class

    29 months

Study Arms (1)

high cardiovascular risk patients

Coronary patients * Elective coronary artery bypass surgery (CABG). * Elective percutaneous coronary intervention (PCI) . * Acute coronary syndromes (acute myocardial infarction with ST elevation (STEMI) and Non ST elevation MI (Non- STEMI) including those treated with primary PCI and/or CABG, and unstable angina). People at high risk of cardiovascular disease (CVD) who have been prescribed one or more of the following medications: (i) blood pressure and/or (ii) lipid and/or (iii) glucose lowering (diet and/or oral hypoglycaemic agents and/or insulin) treatments prescribed by a physician.

Other: There is no intervention

Interventions

high cardiovascular risk patients

Eligibility Criteria

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

I. Participating countries Belgium, Bosnia\&Hertzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, Ireland, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, the Netherlands, Poland, Portugal, Romania, Russia, Serbia, Sweden, Slovenia, Spain, Turkey, Ukraine and the UK.

You may qualify if:

  • I. Coronary patients
  • Patients may fulfil more than one of the following diagnostic criteria:
  • i. Elective CABG. ii. Elective PCI . iii. Acute coronary syndromes (acute myocardial infarction with ST elevation (STEMI) and Non ST elevation MI (Non-STEMI) including those treated with primary PCI and/or CABG, and unstable angina).
  • II. High risk individuals
  • Three diagnostic groups will be identified by their drug treatment:
  • i. Antihypertensive drugs and/or ii. Lipid lowering drugs and/or iii. Glucose lowering treatments (diet and/or oral hypoglycaemics and/or insulin) Patients identified by each of these drug treatments may also be taking one or more of the other drug therapies.

You may not qualify if:

  • I. Coronary patients i. Age \> 80 years ii. Severe physical disability iii. Impaired cognitive function iv. Patients admitted to hospital from outside the geographical area
  • II . High Risk Individuals i. History of coronary heart disease ii. Age \> 80 years iii. Severe physical disability iv. Impaired cognitive function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

London, SW3 6LR, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for measuring lipids, glucose, HbA1c and creatinine

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesVascular Diseases

Study Officials

  • David Wood, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 30, 2018

Study Start

August 23, 2016

Primary Completion

December 28, 2018

Study Completion

December 28, 2018

Last Updated

August 15, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations