Condition category
Circulatory System
Date applied
04/12/2014
Date assigned
26/01/2015
Last edited
26/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A substantial proportion of mortality, morbidity and disability rates in Sweden and internationally is due to myocardial infarctions and strokes. Effective treatments to avoid another event or death are available but the use of these treatments in routine care needs to be improved. The aim of this study is to see whether long-term follow-ups after a myocardial infarction or stroke by specially trained cardiovascular nurses (treatment group) provide a better use of preventive treatment compared to routine follow-ups in primary care (control group) and whether the risk of death or another myocardial infarction or stroke decrease?

Who can participate?
All patients diagnosed with a myocardial infarction or stroke over a period of approximately five years in the county of Jämtland, treated at the county’s only hospital, Östersund Hospital (Sweden).

What does the study involve?
In the treatment group the goal is to rapidly reach and then maintain set treatment targets for blood pressure and blood lipids. Patients in the control group will receive today’s standard of care as usual given by their general practitioner.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
The study is run from Östersund Hospital. Östersund Hospital is the only hospital in the county of Jämtland, Sweden. All patients will be recruited from the county of Jämtland.

When is the study starting and how long is it expected to run for?
January 2010 to December 2017

Who is funding the study?
The study is funded by The Research and Development Unit at Jamtland County Council (Sweden).

Who is the main contact?
Thomas Mooe
thomas.mooe@umu.se

Trial website

Contact information

Type

Scientific

Primary contact

Associated professor Thomas Mooe

ORCID ID

Contact details

Dept. of Public Health and Clinical Medicine
Östersund
Umea University
Hus 10 Plan 5
Östersund
SE-83183
Sweden
+4663154046
thomas.mooe@umu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Secondary preventive, nurse based, telephone follow-up for reduction of cardiovascular events after acute coronary syndrome or stroke: a randomised, controlled, population based study

Acronym

NAILED CV (Nurse based, Age independent Intervention to Limit Evolution of Disease after CardioVascular events)

Study hypothesis

We hypothesised that the NAILED CV (Nurse based, Age independent Intervention to Limit Evolution of Disease after CardioVascular events) Outcome trial would reduce cardiovascular events more effectively than usual care

Ethics approval

The Regional Ethical Review Board, Umeå University, Umeå, Sweden approved on 16th December 2009, ref: Dnr 09-142M, and 10th June 2013, ref: Dnr 13-204-32M

Study design

Single-centre randomised open controlled trial with two parallel groups

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute coronary syndrome, stroke and transient ischemic attack

Intervention

A study nurse will contact patients randomised to the intervention group by phone 1 month after discharge. Before the call a blood sample for lipids will be taken and a standardised blood pressure control will be performed. Blood pressure will be measured after 5 minutes in the sitting position and after 1 minute standing. The tests will be performed by a district nurse, or, for patients in the intervention group living close to the hospital, by a study nurse. Self reported compliance with medication, tobacco use and physical activity will be recorded. During the call the patient will be informed about the test results and if a change in medication is necessary. Tobacco use, physical activity and dietary habits will be discussed. Smoking cessation will be supported. Physical activity of moderate intensity 30 minutes or more most days of the week will be encouraged but also adjusted to the individual patients capacity. Dietary advice to reduce saturated fat and increase the intake of fruit and vegetables will be given. If the patients cholesterol or blood pressure values are above target medication will be adjusted after contact with a study physician. Repeat tests will be taken within approximately 4 weeks and further adjustments made if necessary until target values are reached or no further changes are reasonable. The same routine will be applied after 12 months and thereafter early. The target values are: blood pressure <140 / <90 mmHg (optionally <140 / <85 mmHg in diabetic patients), total cholesterol < 4.5 mmol/l, and low density lipoprotein (LDL) < 2.5 mmol/l (<1.8 in diabetic subjects) to comply with local guidelines.

Patients randomised to the usual care group will also be contacted by phone 1 month after discharge after blood pressure and lipid profile measurements. Self reported compliance, tobacco use and physical activity will be recorded. Their general practitioner who receives the test results (lipid profile and blood pressure) will provide all medical care and no additional intervention will be given as a result of participation in the study. The same routine will be applied after 12 months and thereafter yearly.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Major adverse cardiovascular events at the end of trial defined as:
1. Non-fatal major coronary event: myocardial infarction or coronary revascularisation
2. Non-fatal stroke
3. Cardiovascular death

Secondary outcome measures

1. Separate assessment of the individual components of the primary endpoint
2. Transient ischemic attack
3. All-cause mortality

Overall trial start date

01/01/2010

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients living in the county of Jämtland, Sweden, and hospitalised with a diagnosis of an acute coronary syndrome (ACS, acute myocardial infarction or unstable angina pectoris), stroke (ischemic or hemorrhagic) or transient ischemic attack (TIA) will be assessed for inclusion
1.1. Östersund hospital is the only hospital in the county and all patients, terminal care excluded, with symptoms of an ACS or suspected stroke or TIA are referred for diagnostic evaluation. A routine for identification of all patients in the hospital with a possible ACS or stroke/TIA has been established in previous studies.
2. All patients with a physical and mental capacity to communicate by telephone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1900

Participant exclusion criteria

1. Patients with severe disease
2. Aphasia
3. Dementia
4. Deafness
5. Participation in another trial

Recruitment start date

01/01/2010

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Sweden

Trial participating centre

Dept. of Public Health and Clinical Medicine Umea University, Cardiology, Östersund, SE-83183 Sweden

Sponsor information

Organisation

Jamtland County Council (Sweden)

Sponsor details

The Research and Development Unit
Jamtland County Council
Box 654
Östersund
SE-83127
Sweden
+4663153000
jamtlands.lans.landsting@jll.se

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

The Research and Development Unit, Jamtland County Council (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Main outcome data: anticipated publication date (indicative) 1st September 2018.

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes