The objectives of this study in STEMI patients are as follows:Primary objectives: - To investigate the kinetics of AGEs in the acute phase of STEMI by repeated measurements with the AGE reader® through skin AF, as well as by determining serum AGEs…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are serial measurements of a) skin AF by the AGE reader®
and
b) value of AGEs as measured in serum. Furthermore, cardiac enzymes levels will
be assessed repeatedly to determine the area under the curve for estimation of
the infarct size.
Secondary outcome
Secundary study parameters/outcome are not applicable
Background summary
During the last decades, drastic changes in the management of patients
presenting with an acute ST-elevation myocardial infarction (STEMI) have
substantially improved prognosis at group level. Still, at an individual
patient level, the diagnosis of STEMI has an insecure prognosis. The
identification of the patient who is at high risk of (repeat) acute coronary
syndrome (ACS), including STEMI, poses a major challenge to the treating
cardiologist. The development of methods that results in better risk
stratification and, subsequently, treatment that is tailored to the need of the
individual patient is therefore warranted. The identification (and
implementation) of high-risk biomarkers, such as AGEs, can significantly
contribute to this development. High levels of serum Advanced Glycation
Endproducts (AGEs) and skin autofluorescence (AF) measured by the AGE reader®
seem to be well correlated with coronary heart disease. The change in AGEs
levels as measured in serum and by skin AF during the acute phase and first few
days after admission for ST elevation myocardial infarction (STEMI) through
repeated measurements has not been investigated. Such serial follow-up might
reveal relations between AGEs levels and the clinical course of STEMI patients.
Study objective
The objectives of this study in STEMI patients are as follows:
Primary objectives:
- To investigate the kinetics of AGEs in the acute phase of STEMI by repeated
measurements with the AGE reader® through skin AF, as well as by determining
serum AGEs through repeated blood sampling
- To investigate whether the development of AGEs during the first days after
the infarction is related to myocardial infarct size as measured by the release
of cardiac enzymes
Secondary objectives:
- To investigate the relationship between cardiac enzymes and serum AGEs / skin
AF
- To correlate serial measurements of skin AF levels with serial serum AGEs
levels
Study design
This is a prospective observational pilot study, which will be performed at the
department of Cardiology of the Erasmus MC in Rotterdam. The study sample will
include 40 STEMI patients, who are admitted to the Cardiac Care Unit (CCU) of
the Erasmus MC within 6 hours after symptom onset. As a routine treatment
option for patients presenting with the symptoms and signs of STEMI, primary
percutaneous coronary intervention (PCI) will be conducted in these subjects.
Over four successive days repeated measurements will be implemented with the
AGE reader® and (fasting) blood samples will be taken simultaneously. These
follow-up measurements might be conducted in the Vlietland Ziekenhuis
(Schiedam), the Sint Franciscus Gasthuis (Rotterdam) and the Havenziekenhuis
(Rotterdam), depending on the clinical course of the patient. (Note that most
STEMI patients that undergo primary PCI in the Erasmus MC will be discharged
within 24h to one of the general hospitals in the Rotterdam region)
Study burden and risks
The extra overnight fasting blood samples, that will be drawn on day 2, 3 and
4, form the main burden to the participants of this study. However, by
combining the venipunctures for the purpose of this study with the planned
blood sampling as a part of standard medical care, we will minimise this
burden. Additionally, the patients will be submitted to repeated measurements
of skin AF with the AGE reader®. In our opinion, the risks and burden
associated with these procedures are low and counterbalance the scientific
benefit of this study.
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
Inclusion criteria
- Men and women, aged from 18 year, capable of understanding the study content of and willing to provide written informed consent at admission to the hospital.
- Diagnosis of STEMI, according to the guidelines of the European Society of Cardiology (ESC) 2008. The diagnosis is defined as a history of chest pain / discomfort lasting for
10 - 20 minutes or more (not responding fully to nitroglycerine) with persistent ST segment elevation and elevated markers of myocardial necrosis. Other causes of chest pain / discomfort must be ruled out by the cardiologist.
- Symptom duration <6h.
Exclusion criteria
- Admission for an ACS <6 months
- Clinically significant renal disturbance (GFR (MDRD) <= 30 mL/min/1.73m2) or known renal disease
- Severe inflammatory or current malignant disease
- Darkly coloured skin
- Auto-immune / connective tissue disease
- Aorta dissection
- Comatose at admission to the CCU
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 | NL40381.078.12 |