Condition category
Circulatory System
Date applied
13/02/2006
Date assigned
10/03/2006
Last edited
30/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.refonet.de

Contact information

Type

Scientific

Primary contact

Dr Wolfgang Mayer-Berger

ORCID ID

Contact details

Roderbirken 1
Leichlingen
42799
Germany
+49 (0)217 5824010
wolfgang.mayer-berger@klinik-roderbirken.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Sekona

Study hypothesis

Structured aftercare leads to:
1. Reduction in the long-term risk of the occurrence of any cardiac event
2. Slowing down of atherosclerosis
3. Quality of life improvement
4. Reduction in the direct and indirect costs involved, including delayed pension claims

Ethics approval

Ethics Committee of the Physicians Chamber, North Rhein, Dusseldorf, Germany 22/07/2004, reference number 2004093

Study design

Prospective randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Coronary heart disease

Intervention

Secondary cardiac prevention program with reminders and follow-up education after remission for up to 18 months versus usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Reduction of the 10-year risk of the occurrence of any cardiac event

Secondary outcome measures

1. Regression or slower progression of atherosclerosis as measured by the carotidal intima-media-thickness
2. Quality of life improvement
3. Reduction in the direct and indirect costs involved, including delayed pension claims

Overall trial start date

01/09/2004

Overall trial end date

01/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Membership of the German Pension Insurance Fund, Rhineland
2. Younger than 58 years old
3. Overt coronary heart disease
4. Participants must sign an informed consent form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Heart failure according to the New York Hearth Association (NYHA) classification III or IV
2. Any prognostic limiting illness
3. Limiting pulmonary disease (forced expiratory volume in one second [FEV 1] lower than 35%)
4. Cognitive problems or problems with understanding
5. Low mobility

Recruitment start date

01/09/2004

Recruitment end date

01/03/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Roderbirken 1
Leichlingen
42799
Germany

Sponsor information

Organisation

Refonet (Germany)

Sponsor details

Burgweg 3
Bad Neuenahr-Ahrweiler
53445
Germany
+49 (0)264 190620
service@refonet.de

Sponsor type

Research organisation

Website

http://www.refonet.de

Funders

Funder type

Research organisation

Funder name

Refonet (Germany)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/23111536

Publication citations

  1. Results

    Mayer-Berger W, Simic D, Mahmoodzad J, Burtscher R, Kohlmeyer M, Schwitalla B, Redaèlli M, Efficacy of a long-term secondary prevention programme following inpatient cardiovascular rehabilitation on risk and health-related quality of life in a low-education cohort: a randomized controlled study., Eur J Prev Cardiol, 2014, 21, 2, 145-152, doi: 10.1177/2047487312465526.

Additional files

Editorial Notes