To decrease the PROCAM risk score by participation in a lifestyle-intervention.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are the decrease in PROCAM risk score due to lifestyle
intervention.
Secondary outcome
Secundaire study parameter is the decrease in concentration of CRP, MPO en
PAPP-A.
As described in the amendment:
Identification of the circulating forms of cardiac Troponin and its fragments
present after the run.
Background summary
In modern western world cardiovascular disease is frequently seen. Lack of
exercise and an unhealthy diet are factors that increase the chance of
cardiovascular disease. Knowledge of the cardiovascular risk score and
awareness of lifestyle will help to prevent cardiovascular disaese. This is the
aim of the HAPPY program wich is the acronym for Heart Attack Prevention
Program for You.
As described in the amendment:
Identifying the circulating forms of cTnT or cTnI allows us to acquire
knowledge on their release mechanism from the cardiomyocyte, e.g. in the intact
form or degraded. We aim to identify the circulating forms of cTnT and cTnI
after running 5 or 15 km in the Maastrichts Mooiste trip, using a highly
sensitive immunoprecipitation assay combined with western blotting. This
knowledge will provide new information for physicists on how to interpret the
minor troponin elevations seen after exercise, i.e. is this reversible cardiac
damage or irreversible damage?
Study objective
To decrease the PROCAM risk score by participation in a lifestyle-intervention.
Study design
In june Maastrichts Mooiste run will be organised. The aim of this event is to
get people to exercise more and live healthier.
In this study 1000 participants at Maastrichts Mooiste will be included. In
preperation of the run there will be two "healthchecks". In the period of 3
months between these checks, the participants will be offered a number of
voluntary exercise clinics and diet advise.
Before the inventions the first healthcheck takes place in wich blood is drawn
from the participants. From certain blood parameters the PROCAM riskscore will
be determined. In addition a number of novel cardiovascular biomarkers will be
assessed. Moreover the length, weight, bellycontour and bloodpressure will be
meassured.
Hereafter the participants will be participate in a voluntary lifestyle, which
includes exercise clinics and diet advise.
Three monds later there will be a second healthcheck, which is similar to the
first healthcheck. The calculated PROCAM riskscore will be communicated to the
participants by mail and will be accompanied by an appropriate advise.
As described in the amendment:
Serum samples from participants participating in Maastrichts Mooiste (5 or 15
km) will be analyzed for cTnT and cTnI with the currently available troponin
immunoassays.
Study burden and risks
All participants will undergo venapunction, the risk are minimal.
The excercise clinics are voluntary.
Universiteitssingel 50
6229 ER Maastricht
Nederland
Universiteitssingel 50
6229 ER Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Participants in the Maastrichts Mooiste
Age above 18 years
Exclusion criteria
age under 18 years
no signed informed consent
incapable of participate in exercise clinics
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16250.068.07 |