Condition category
Circulatory System
Date applied
26/12/2008
Date assigned
19/02/2009
Last edited
19/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carmen Suarez

ORCID ID

Contact details

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

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

  1. 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.

  2. 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.

Additional files

Editorial Notes