Secondary prevention for inpatients with coronary artery disease in rehabilitation and conceptual aftercare
| ISRCTN | ISRCTN15954342 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15954342 |
| Protocol serial number | N/A |
| Sponsor | Refonet (Germany) |
| Funder | Refonet (Germany) |
- Submission date
- 13/02/2006
- Registration date
- 10/03/2006
- Last edited
- 30/09/2014
- 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 Wolfgang Mayer-Berger
Scientific
Scientific
Roderbirken 1
Leichlingen
42799
Germany
| Phone | +49 (0)217 5824010 |
|---|---|
| wolfgang.mayer-berger@klinik-roderbirken.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Sekona |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
Reduction of the 10-year risk of the occurrence of any cardiac event |
| Key secondary outcome measure(s) |
1. Regression or slower progression of atherosclerosis as measured by the carotidal intima-media-thickness |
| Completion date | 01/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 600 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/03/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
Roderbirken 1
Leichlingen
42799
Germany
42799
Germany
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 | 01/02/2014 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
