Impact of comprehensive and intensive treatment of risk factors concerning cardiovascular mortality in secondary prevention: MIRVAS study

ISRCTN	ISRCTN93700442
DOI	https://doi.org/10.1186/ISRCTN93700442
Protocol serial number	N/A
Sponsor	La Princesa University Hospital (Hospital Universitario de La Princesa) (Spain)
Funder	La Princesa University Hospital (Hospital Universitario de La Princesa), Biomedical Research Foundation (Fundación de Investigación Biomédioca) (Spain)

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

Hospital Universitario de La Princesa
Diego de Leon 62
Madrid
28006
Spain

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/07/2007		Yes	No
Results article	results	01/03/2008		Yes	No