Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS study
ISRCTN | ISRCTN93700442 |
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DOI | https://doi.org/10.1186/ISRCTN93700442 |
Secondary identifying numbers | N/A |
- Submission date
- 26/12/2008
- Registration date
- 19/02/2009
- Last edited
- 19/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Carmen Suarez
Scientific
Scientific
Hospital Universitario de La Princesa
Diego de Leon 62
Madrid
28006
Spain
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Prevention |
Scientific title | Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS study - a randomised controlled trial |
Study acronym | MIRVAS |
Study objectives | 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(s) | 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). |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/09/2002 |
Completion date | 01/09/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 80 Years |
Sex | Both |
Target number of participants | 247 |
Key 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 |
Key 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 |
Date of first enrolment | 01/09/2002 |
Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Universitario de La Princesa
Madrid
28006
Spain
28006
Spain
Sponsor information
La Princesa University Hospital (Hospital Universitario de La Princesa) (Spain)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr Carmen Suarez
Diego de Leon 62
Madrid
28006
Spain
Website | http://www.madrid.org/cs/Satellite?pagename=HospitalLaPrincesa/Page/HPRI_home |
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https://ror.org/03cg5md32 |
Funders
Funder type
University/education
La Princesa University Hospital (Hospital Universitario de La Princesa), Biomedical Research Foundation (Fundación de Investigación Biomédioca) (Spain)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 14/07/2007 | Yes | No | |
Results article | results | 01/03/2008 | Yes | No |