Primary Objective:- To assess lipid levels of STEMI patients over a long course. Secondary Objectives:- To assess the association between poorly controlled cholesterol and (apo) lipoprotein levels for the long term outcome in STEMI patients.- To…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Association between baseline characteristics, place of referral and
poorly controlled lipid levels.
Secondary outcome
- A major coronary event after one year follow up (defined as death from CHD,
nonfatal non*procedure-related myocardial infarction, or resuscitation after
cardiac arrest), a cerebrovascular event, hospitalization for congestive heart
failure, peripheral-artery disease, death from any cause, any cardiovascular
event, and any coronary event.
- Statin compliance using the MMAS (Morisky Medical Adherence Scale).
Background summary
Over seven million people die from CAD every year, accounting for 12.8% of all
deaths. In the Leiden University Medical Center patients with a ST-segment
elevated myocardial infarction (STEMI) are treated according to the MISSION!
Protocol. This protocol was implemented in 2004 and contains a clinical
framework designed to optimize the care of STEMI patients. However, treatment
of these patients remains suboptimal, in particular regulation of lipids, which
is a well-known risk factor for recurrent cardiac events. Analysis shows that 2
years after STEMI, only 9.3% of all patients reach the target level of
1.8mmol/L for low density lipids (LDL) cholesterol. In addition, less than 50%
of the patients were statin therapy compliant 1 year after STEMI.
Study objective
Primary Objective:
- To assess lipid levels of STEMI patients over a long course.
Secondary Objectives:
- To assess the association between poorly controlled cholesterol and (apo)
lipoprotein levels for the long term outcome in STEMI patients.
- To assess factors associated with poorly controlled lipid levels.
- Assessment of long term statin compliance using the MMAS scale.
Study design
Prospective observational cohort study.
Study burden and risks
Patients will be asked to visit the hospital once or twice for a blood sample
and to fill in a questionnaire. The risk of complications with a venipuncture,
such as syncope or phlebitis is considered to below.
The outcome of this study might benefit future lipid regulations and associated
outcomes in STEMI patients. This study will provide insight in medication
compliance in STEMI patients and whether this is associated with type of health
care professional controlling the lipid levels.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
- All consecutive patients with ST-elevated myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) treated by the MISSION! Protocol from 01-02-2004 to 31-12-2013.
* STEMI is defined as ongoing chest pain (>30 minutes), accompanied with ST-elevation (*0.2
mV in *2 leads in V1-V3 or *0.1 mV in other leads) or presumed new left bundle branch block (LBBB) and a typical rise and fall of cardiac biomarkers. Patients with a cardiac arrest are only analyzed if there is return of spontaneous circulation at the time of treatment in the catheterization lab.;- Place of residency area Hollands-Midden Noord at the time of index infarction.;- Measured lipid spectrum (Total-cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides) at the time of index infarction.
Exclusion criteria
- Patients with other acute coronary syndromes as non-ST-elevated myocardial infarction or unstable angina pectoris, not treated with primary PCI are excluded. Patients will also be excluded in case of cardiac arrest without return of spontaneous circulation at the time of primary PCI.;- If the permanent residence of the patient is not in the Netherlands, follow-up for clinical outcomes can be difficult. For this reason these patients will be eliminated for clinical outcome analysis.;- Not completed outpatient follow up according to the MISSION! guidelines, up to one year following index infarction.
Design
Recruitment
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 | NL55078.058.15 |