Secondary prevention for inpatients with coronary artery disease in rehabilitation and conceptual aftercare

ISRCTN	ISRCTN15954342
DOI	https://doi.org/10.1186/ISRCTN15954342
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Dr Wolfgang Mayer-Berger
Scientific

Roderbirken 1
Leichlingen
42799
Germany

Phone	+49 (0)217 5824010
Email	wolfgang.mayer-berger@klinik-roderbirken.de

Study design	Prospective randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title
Study 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(s)	Ethics Committee of the Physicians Chamber, North Rhein, Dusseldorf, Germany 22/07/2004, reference number 2004093
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
Primary outcome measure	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 study start date	01/09/2004
Overall study end date	01/03/2007

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	600
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 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

Roderbirken 1

Leichlingen
42799
Germany

Refonet (Germany)
Research organisation

Burgweg 3
Bad Neuenahr-Ahrweiler
53445
Germany

Research organisation

Refonet (Germany)

No information available

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2014		Yes	No