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ISRCTN
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ISRCTN93700442
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ClinicalTrials.gov identifier
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Public title
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Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS study
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Scientific title
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Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS study - a randomised controlled trial
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Acronym
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MIRVAS
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Serial number at source
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N/A
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Study hypothesis
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Patients with coronary and cerebrovascular disease receiving secondary prevention care through a comprehensive and intensive cardiovascular risk factors control can reduce cardiovascular morbidity and mortality at three years after the cardiovascular event.
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Lay summary
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Ethics approval
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Ethics and Research Committee of La Princesa University Hospital (Hospital Universitario de La Princesa). Formal written approval was granted on 01/07/2005 (ref: PI-77) (Initial approval was given orally in 2002).
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Study design
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Randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Secondary prevention of cardiovascular disease
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Participants - inclusion criteria
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1. Both males and females, from 18 to 80 years old
2. Patients admitted to the hospital for acute coronary syndrome (with or without ST-segment elevation) or an ischaemic stroke
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Participants - exclusion criteria
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1. Refusal or inability to participate in the follow-up (displaced patients or with reduced mobility)
2. Life expectancy of less than 12 months
3. Severe cognitive deterioration
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Anticipated start date
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01/09/2002
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Anticipated end date
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01/09/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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247
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Interventions
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The MIRVAS study is a randomised controlled trial conducted at La Princesa University Hospital. Patients were included in the study between September 2002 and February 2004.
On the day of admission to the hospital, the patients allocated to the intervention group received a health education talk by a trained nurse, who informed them of the meaning of their illness and the importance of carrying out the treatment properly. Later visits were scheduled at 2, 5, 12, 24 and 36 months after the acute episode with more reviews being able to be carried out if deemed appropriate. In addition, patients could see other specialists connected with their cardiovascular disease. The talk made during each visit consisted of a speech by a nurse (health education, change in lifestyle, assessing treatment adherence) and a medical assessment (clinical evaluation and modification of treatment if appropriate).
The patients in the control group received the routine follow-up in the cardiology or neurology consultations, and/or in primary care. They had annual appointments and their lifestyle habits, drug treatment they received, degree of control of the different cardiovascular risk factors (CVRF) and the presence or absence of symptoms, visits to the emergency ward and/or hospital visits for any reason were all recorded.
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Primary outcome measure(s)
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The following were assessed at three-year follow-up:
1. Cardiovascular mortality and cardiovascular morbimortality, which included the following events: 1.1. Cardiovascular death
1.2. Acute coronary syndrome with or without ST-segment elevation
1.3. Acute stroke (ischaemic or haemorrhagic)
1.4. Revascularisation in any area
1.5. Amputation as a result of peripheral ischaemia
2. Admittance due to heart failure
3. Control of risk factors
All episodes were understood as such if they had a clinical report to back them up. The assessments were carried out by an unblinded member of the research group.
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Secondary outcome measure(s)
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The following were assessed at 1 and 3 years:
1. Percentage of patients who reached the optimal control of each risk factor
2. Percentage of pharmacological interventions recommended by international guidelines for secondary prevention of cardiovascular risk received in each arm
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Sources of funding
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La Princesa University Hospital (Hospital Universitario de La Princesa), Biomedical Research Foundation (Fundación de Investigación Biomédioca) (Spain)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17683704
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18275764
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Contact name
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Dr
Carmen
Suarez
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Address
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Hospital Universitario de La Princesa
Diego de Leon 62
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City/town
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Madrid
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Zip/Postcode
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28006
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Country
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Spain
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Sponsor
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La Princesa University Hospital (Hospital Universitario de La Princesa) (Spain)
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Address
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c/o Dr Carmen Suarez
Diego de Leon 62
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City/town
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Madrid
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Zip/Postcode
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28006
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Country
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Spain
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Sponsor website:
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http://www.madrid.org/cs/Satellite?pagename=HospitalLaPrincesa/Page/HPRI_home
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Date applied
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26/12/2008
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Last edited
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19/02/2009
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Date ISRCTN assigned
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19/02/2009
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