Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS study - a randomised controlled trial
Acronym
MIRVAS
Study hypothesis
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.
Ethics approval
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).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Secondary prevention of cardiovascular disease
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
01/09/2002
Overall trial end date
01/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
247
Participant exclusion criteria
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
Recruitment start date
01/09/2002
Recruitment end date
01/09/2006
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Universitario de La Princesa
Madrid
28006
Spain
Sponsor information
Organisation
La Princesa University Hospital (Hospital Universitario de La Princesa) (Spain)
Sponsor details
c/o Dr Carmen Suarez
Diego de Leon 62
Madrid
28006
Spain
Sponsor type
Hospital/treatment centre
Website
http://www.madrid.org/cs/Satellite?pagename=HospitalLaPrincesa/Page/HPRI_home
Funders
Funder type
University/education
Funder name
La Princesa University Hospital (Hospital Universitario de La Princesa), Biomedical Research Foundation (Fundación de Investigación Biomédioca) (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17683704
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18275764
Publication citations
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Results
de Pablo CC, Palanco MA, Sanz PI, Luis CS, Portillo AP, Fernández CS, [Control of risk factor in diabetic patients in secondary prevention. MIRVAS Study]., Rev Clin Esp, 2008, 208, 3, 118-123.
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Moreno Palanco MA, Ciria de Pablo C, Ibáñez Sanz P, Sánchez Luis C, Pizarro Portillo A, Suárez Fernández C, [Cardiovascular morbimortality reduction after an acute cardiovascular event through multifactorial and intensive cardiovascular risk factors management (MIRVAS project)]., Med Clin (Barc), 2007, 129, 7, 241-246.