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EUROACTION - A European wide effort to raise the standards of preventive cardiology
ISRCTN ISRCTN71715857
DOI 10.1186/ISRCTN71715857
ClinicalTrials.gov identifier
EudraCT number
Public title EUROACTION - A European wide effort to raise the standards of preventive cardiology
Scientific title
Acronym EUROACTION
Serial number at source N/A
Study hypothesis The aim of the study is to raise standards of preventive cardiology in Europe by demonstrating that the recommended European lifestyle, risk factor and therapeutic goals in cardiovascular prevention are achievable and sustainable in everyday clinical practice.

EUROACTION is organised as a cluster randomised controlled intervention trial. In each of six countries a pair of general hospitals (12 in total) and a pair of general practices (12 in total) are recruited. Hospitals and general practices are randomised within pairs to receive the EUROACTION programme or to be monitored for usual care. The proportion of patients and family members achieving the European lifestyle, risk factor and therapeutic goals in the EUROACTION programme will be compared with usual care at one year.

On completion, the EUROACTION programme will be offered to national professional societies and heart foundations, as an evaluated practice model for preventive cardiology.
Lay summary Not provided at time of registration
Ethics approval Ethics approval not yet gained as of 12th September 2006.
Study design Cluster randomised controlled trial
Countries of recruitment Denmark, France, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom
Disease/condition/study domain Coronary Heart Disease (CHD)
Participants - inclusion criteria Hospital arm:
1. In- and out-hospital patients who meet the inclusion criteria and who agree to participate in the trial. Within each hospital (both intervention and usual care) all consecutive new patients with medical diagnosis of Coronary Heart Disease (CHD) (see below), men and women under 80 years of age, will be identified:
1.1. Acute coronary syndromes, unstable angina, non Q wave Myocardial Infarction (MI), Q wave MIb
1.2. Stable angina pectoris
2. Partners of patients living in the same household
3. First degree blood relatives of patients with premature CHD

Primary Care arm:
1. High risk individuals who meet the following inclusion criteria and who agree to participate in the trial. Men and women, 50 years of age or older, but less than 80 years, without history of coronary heart disease were identified in three categories as follows:
1.1. High multifactorial risk individuals: CVD risk more than or equal to 5% over ten years (now or projected to age 60 years), according to the HeartScore risk estimation system
1.2. Antihypertensive and/or lipid-lowering therapies initiated in the last year
1.3. New or known diabetes diagnosed in the last three years
2. Partners of high-risk individuals living in the same household
Participants - exclusion criteria Hospital arm:
1. Aged 80 years of age or older
2. Severe heart failure
3. Impaired cognitive function
4. Severe physical disability

Primary Care arm:
1. Under 50 and over 80 years of age
2. Mentally or physically incapable
Anticipated start date 08/04/2003
Anticipated end date 30/04/2006
Status of trial Completed
Patient information material
Target number of participants 10,000
Interventions EUROACTION brings together a multidisciplinary team, comprising cardiologists, general practitioners, specialist nurses, dieticians, and physiotherapists and physical activity specialists to show that the Guidelines can be followed and lifestyle, risk factor and therapeutic goals achieved.
Primary outcome measure(s) Hospital arm:
1. Coronary patients: Proportions of patients achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention:
1.1. Smoking habit (self reported, breath carbon monoxide (CO)
1.2. Diet/nutrition (self reported, food habit questionnaire, 24 hour recall with analysis)
1.3. Physical activity (self reported, step counter, incremental shuttle walk test, international physical activity questionnaire)
1.4. Overweight/obesity (Body Mass Index [BMI], waist circumference)
1.5. Diabetes (known/new, fasting and random plasma glucose, glycated haemoglobin (Hb A1c), Glucose Tolerance Test (GTT)
1.6. Blood pressure (automatic sphygmomanometer)
1.7. Total cholesterol, High-Density Lipoprotein (HDL) cholesterol, triglycerides, calculated Low-Density Lipoprotein (LDL) cholesterol)
1.8. Prophylactic drug therapies: nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs, antiplatelets, beta-blockers, Angiotensin Converting Enzyme (ACE)-inhibitors, lipid-lowering drugs, anticoagulants, hypoglycaemic drugs
2. Partners and first-degree relatives of patients with premature coronary disease living in the same household: Proportions of partners and first degree relatives achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention:
2.1. Smoking habit (self reported, breath CO)
2.2. Diet/nutrition (self reported, food habit questionnaire, 24 hour recall with analysis)
2.3. Physical activity (self reported, step counter, international physical activity questionnaire)
2.4. Overweight/obesity (BMI, waist circumference)
2.5. Diabetes (known/new, fasting and random plasma glucose, Hb A1c)
2.6. Blood pressure (automatic sphygmomanometer)
2.7. Total cholesterol, HDL cholesterol, triglycerides, calculated LDL cholesterol)
2.8. Prophylactic drug therapies: nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs, antiplatelets, beta-blockers, ACE-inhibitors, lipid-lowering drugs, anticoagulants, hypoglycaemic drugs
3. First-degree relatives of patients with premature coronary disease not living in the same household: Proportions of first degree relatives achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention:
3.1. Smoking habit (self reported)
3.2. Diet/nutrition (self reported)
3.3. Physical activity (self reported)
3.4. Overweight/obesity (BMI)
3.5. Diabetes (known/new, fasting and random plasma glucose)
3.6. Blood pressure
3.7. Total cholesterol, HDL cholesterol, triglycerides, calculated LDL cholesterol
3.8. Prophylactic drug therapies: nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs, antiplatelets, beta-blockers, ACE-inhibitors, lipid-lowering drugs, anticoagulants, hypoglycaemic drugs

Primary Care:
1. High-risk individuals: Proportions of high risk individuals achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention:
1.1. Smoking habit (self reported, breath CO)
1.2. Diet/nutrition (self reported, food habit questionnaire)
1.3. Physical activity (self reported, step counter, Chester step test)
1.4. Overweight/obesity (BMI, waist circumference)
1.5. Diabetes (known/new, fasting and random plasma glucose, HBA1c)
1.6. Blood pressure (automatic sphygmomanometer)
1.7. Total cholesterol, HDL cholesterol, triglycerides, calculated LDL cholesterol
1.8. Prophylactic drug therapies: antiplatelets, ACE-inhibitors, lipid-lowering drugs, hypoglycaemic drugs, nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs
2. Partners of high-risk individuals living in the same household: Proportions of partners achieving European and national lifestyle, risk factors and therapeutic targets for cardiovascular disease prevention:
2.1. Smoking habit (self reported, breath CO)
2.2. Diet/nutrition (self reported, food habit questionnaire)
2.3. Physical activity (self reported, step counter)
2.4. Overweight/obesity (BMI, waist circumference)
2.5. Diabetes (known/new, fasting and random plasma glucose, HbA1c)
2.6. Blood pressure (automatic sphygmomanometer)
2.7. Total cholesterol, HDL cholesterol, triglycerides, calculated LDL cholesterol
2.8. Prophylactic drug therapies: nicotine replacement therapy, bupropion hydrochloride, antiobesity drugs, antiplatelets, ACE-inhibitors, lipid-lowering drugs, hypoglycaemic drugs
Secondary outcome measure(s) Hospital arm:
1. Coronary patients:
1.1. Psychosocial, depression (Hospital Anxiety and Depression (HAD) scale), compliance (self reported), health beliefs (health beliefs questionnaire), emotional state (global mood scale), illness perception (illness perception questionnaire), functional limitation (SF 36 questions)
1.2. Return to work
1.3. Service use
1.4. Health economics (EuroQoL questionnaire)
1.5. Cardiovascular events (recurrent nonfatal coronary and cardiovascular events and cardiovascular/total mortality)
2. Partners and first-degree relatives of patients with premature coronary disease living in the same household:
2.1. Psychosocial, depression (Hospital Anxiety and Depression (HAD) scale), compliance (self reported), health beliefs (health beliefs questionnaire), emotional state (global mood scale), illness perception (illness perception questionnaire), functional limitation (SF 36 questions)
2.2. Service use
2.3. Health economics (EuroQoL questionnaire)
2.4. Cardiovascular events (recurrent nonfatal coronary and cardiovascular events and cardiovascular/total mortality)

Primary Care:
1. High-risk individuals:
1.1. Psychosocial, depression (Hospital Anxiety and Depression (HAD) scale), health beliefs and views about heart disease (health beliefs questionnaire), risk perception (risk perception questionnaire), functional limitation (SF 36 questions)
1.2. Service use
1.3. Health economics (EuroQoL questionnaire)
1.4. Cardiovascular events (nonfatal coronary and cardiovascular events and cardiovascular/total mortality)
2. Partners of high-risk individuals living in the same household:
2.1. Psychosocial, depression (Hospital Anxiety and Depression (HAD) scale), health beliefs and views about heart disease (health beliefs questionnaire), risk perception (risk perception questionnaire), functional limitation (SF 36 questions)
2.2. Service use
2.3. Health economics (EuroQoL questionnaire)
2.4. Cardiovascular events (nonfatal coronary and cardiovascular events and cardiovascular/total mortality)
Sources of funding 1. European Society of Cardiology (France)
2. AstraZeneca International - unconditional educational grant
Trial website http://www.escardio.org/Policy/Pages/EuroAction.aspx
Publications 1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18555911
2. 2012 cost-effectiveness in http://www.ncbi.nlm.nih.gov/pubmed/23065443
Contact name Prof  David  Wood
  Address 5th Floor Laboratory Block
Imperial College
Charing Cross Hospital
Fulham Palace Road
  City/town London
  Zip/Postcode W6 8RF
  Country United Kingdom
  Tel +44 (0)20 8846 1258
  Fax +44 (0)20 8846 7679
  Email d.wood@imperial.ac.uk
Sponsor European Society of Cardiology (France)
  Address European Heart House
2035 Route des Colles
Les Templiers - BP 179
F-06903 Sophia Antipolis Cedex
  City/town Nice
  Zip/Postcode F-06903
  Country France
  Tel +33 4 92 94 76 00
  Fax +33 4 92 94 76 01
  Email fheraud@escardio.org
  Sponsor website: http://www.escardio.org
Date applied 05/07/2005
Last edited 16/10/2012
Date ISRCTN assigned 12/09/2006
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