Condition category
Circulatory System
Date applied
16/09/2016
Date assigned
01/10/2016
Last edited
05/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.bellvitgehospital.cat/

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

Results - basic reporting

See additional file ISRCTN17382091_BasicResults_27Sep16

Publication summary

Publication citations

Additional files

Editorial Notes

05/10/2016: The participant information sheet and basic results have been uploaded