Plain English Summary
Background and study aims
Coronary artery disease (CAD), also known as ischemic heart disease, is one of the leading causes of death worldwide. CAD develops because of the build-up of fatty deposits (plaque) on the walls of the coronary arteries (the arteries that supply the heart with oxygen-rich blood). It is the leading cause of death in older adults, and its consequences are a major source of long-term disability, loss of independence and impaired quality of life. In patients with CAD, it is important to control cardiovascular risk factors (factors that put a person at risk of having a cardiovascular event, such as a stroke or heart attack) and improve the lifestyle in order to reduce the risk of a relapse. There are lots of studies in younger patients, but in older patients there is a lack of data. The aim of this study is to look at older patients with CAD to compare two different ways for achieving the control of cardiovascular risk factors and improve the lifestyle during the year after discharge.
Who can participate?
Patients aged 70 and over who have been diagnosed with CAD and admitted to the Cardiology Department of the Bellvitge University Hospital.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive lifestyle recommendations (such as how to get more exercise and follow a Mediterranean diet) and changes in their drug treatment when needed to help lower their cardiovascular risk factors, as well as receiving standard care. Those in the second group receive standard care which involves being given lifestyle recommendations and drug treatment prescribed by their general practitioner and cardiologist. At the start of the study and after 12 months, participants in both groups complete a number of questionnaires and physical test to see if their cardiovascular risk factors have changed. In addition, participants are followed up 3 years later to find out how many are still living.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involves with participating.
Where is the study run from?
Vascular Risk Unit of Bellvitge Hospital (Spain_
When is the study starting and how long is it expected to run for?
September 2004 to June 2014
Who is funding the study?
Bellvitge University Hospital-IDIBELL (Spain)
Who is the main contact?
Dra. Elisenda Marcos Forniol
emarcos@fundaciovallparadis.cat
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Elisenda Marcos
ORCID ID
http://orcid.org/0000-0003-2348-8283
Contact details
Bellvitge University Hospital
Vascular Risk Unit
c/Feixa Llarga
sn
Hospitalet de Llobregat
Barcelona
08907
Spain
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
S/N
Study information
Scientific title
Is a secondary prevention program compared with usual care effective to improve the achievement of cardiovascular risk factors goals in patients ≥ 70 years old with recent acute coronary syndrome?
Acronym
Study hypothesis
The aim of this study is to ascertain the effects of a secondary prevention programme of cardiovascular disease on the control of CVRF, lifestyle, quality of life and functionality in elderly patients with a recent coronary event.
Ethics approval
Ethics board of Bellvitge University Hospital, 28/11/2011, ref: PR292/11
Study design
Open randomised intervention study with parallel groups
Primary study design
Interventional
Secondary study design
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
See additional files
Condition
Coronary heart disease
Intervention
Patients will be recruited before hospital discharge, and are randomized to an intervention or control group within the next three months. Patients will be randomised by a balanced randomised block method.
Intervention group: Participants will attend appointments at baseline, 3, 6, 9 and 12 months. During this time, participants continue to will receive their usual care through their family physicians and cardiologist. At the appointments at baseline and 12 months, participants are assessed by a physician, a nurse and a nutritionist. At the appointments a nurse takes the blood pressure, heart rate, weight and height (only at baseline), and participants will complete the Short Physical Performance Battery (SPPB) and the Yesavage questionnaire. The nurse will also give give physical activity counselling to improve lifestyle. The nutritionist will perform a food-frequency questionnaire and the Short Form 36 Health Survey (SF-36). Furthermore she will give dietary recommendations to improve adherence to the Mediterranean diet. The physician will conduct medical history, a physical examination and revise the blood test performed the week before. They will also indicate changes in drug treatment when needed to improve the cardiovascular risk factors goals for the secondary prevention of cardiovascular disease. At the appointments at 3, 6 and 9 months, , patients will be assessed by the nurse and the physician. A week before a blood test will be performed. The nurse will take the blood pressure, heart rate and weight. The physician will assess clinical, physical and blood test areas in order to make modifications to the treatment if need, and remind patients the initial physical activity, diet and lifestyle recommendations.
Control group: Participants will receive their usual care through their family physicians and cardiologist, that is the normal procedure after a discharge from hosptial.
At baseline and 12 months, participants will attend an appointment at which they are assessed by a physician, a nurse and a nutritionist in order to collect the data. At the appointments a nurse will take the blood pressure, heart rate, weight and height (only at baseline), and participants will complete the Short Physical Performance Battery (SPPB) and the Yesavage questionnaire. The nutritionist will perform a food-frequency questionnaire and the Short Form 36 Health Survey (SF-36). The physician will conduct medical history, a physical examination and revise the blood test performed the week before.
Three years after the intervention finished, mortality was evaluated.
Intervention type
Mixed
Phase
Drug names
Primary outcome measure
1. Blood pressure is measured during patient interviews using a digital sphygmomanometer at baseline and 12 months
2. LDL cholesterol is measured by a fasting blood test performed the week before the appointments at baseline and 12 months
3. Smoking status is assessed during patient interviews at baseline and 12 months
4. Body mass index is caclulated during patient interview using the weight and height measurements at baseline and 12 months
5. Physical activity is measured using the Metabolic Equivalent of Task (MET) h/wk during patient interviews at baseline and 12 months
6. Glycosylated haemoglobin is measured by a fasting blood test performed the week before the appointments at baseline and 12 months
Secondary outcome measures
1. Adherence to the Meditrranean Diet is measured with a nine-item score (Martínez- González, 2004) calculated from the food-frequency questionnaire performed during patient interview at baseline and 12 months
2. Quality of life is measured using the Short Form 36 Health Survey at baseline and 12 months
3. Physical performance is measured using the Short Physical Performance Battery (SPPB) during patient interviews at baseline and 12 months
4. Mortality rate is assessed three years after the 12-month follow-up using clinical records and the National Death Index
Overall trial start date
01/01/2004
Overall trial end date
30/06/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Consecutive patients ≥ 70 years old
2. Diagnosed of acute coronary syndrome
3. Admitted to the Cardiology Department of the Bellvitge University Hospital
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
120
Participant exclusion criteria
1. Diagnosis of cancer
2. Functional dependence (Barthel Index score ≤ 75)
3. Cognitive impairment (Pfeiffer’s Short Portable Mental State Questionnaire > 5 mistakes)
4. Difficulties attending appointments
5. Very low life expectancy
Recruitment start date
01/09/2004
Recruitment end date
31/03/2007
Locations
Countries of recruitment
Spain
Trial participating centre
Bellvitge University Hospital-IDIBELL
Vascular Risk Unit
Internal Medicine Department
Feixa Llarga s/n
Hospitalet de Llobregat
Barcelona
08907
Spain
Sponsor information
Organisation
Bellvitge University Hospital-IDIBELL
Sponsor details
Vascular Risk Unit
Internal Medicine Department
Feixa Llarga
s/n
L'Hospitalet de Llobregat
Barcelona
08907
Spain
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Bellvitge University Hospital-IDIBELL
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study will be available upon request from Dr Elisenda Marcos Forniol (elimarcos@gmail.com)
Intention to publish date
31/12/2016
Participant level data
Available on request
Basic results (scientific)
See additional file ISRCTN17382091_BasicResults_27Sep16
Publication list
Publication citations
Additional files
- ISRCTN17382091_BasicResults_27Sep16.docx Basic results uploaded 05/10/2016
- ISRCTN17382091_PIS_27Sep2016_Spanish.docx Participant information sheet uploaded 05/10/2016