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van CCT (UK)

Repeatedly measuring the level of Advanced Glycation Endproducts (AGEs) in the acute phase of a myocardial infarction.

- candidate number13382
- NTR NumberNTR3639
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-sep-2012
- Secondary IDs2012-285 / NL4038107812; METC ErasmusMC / CCMO
- Public TitleRepeatedly measuring the level of Advanced Glycation Endproducts (AGEs) in the acute phase of a myocardial infarction.
- Scientific TitleRepeated measurements in patients presenting with ST-segment elevation myocardial infarction of Advanced Glycation Endproducts by skin autofluorescence and serum analysis: A pilot study (STAGE study).
- hypothesisSerial follow-up measurements might reveal AGEs as a biomarker of (initial) clinical outcome in patients presenting with STEMI.
- Healt Condition(s) or Problem(s) studiedST-segment elevation myocardial infarction (STEMI), Acute coronary syndrome (ACS), Myocardial infarction
- Inclusion criteriaThe following inclusion criteria will be applied (all criteria should apply):
1. Men and women, aged from 18 to 70 years, capable of understanding the study content of and willing to provide written informed consent at admission to the hospital;
2. 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 ¨C 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;
3. Symptom duration <6h;
4. Blood is drawn before PCI.
- Exclusion criteriaPatients with at least one of the following characteristics will be excluded:
1. Myocardial ischemia precipitated by a condition other than atherosclerotic coronary artery disease;
2. Admission for an ACS and / or interventions < 6 months;
3. Diabetes Mellitus;
4. Other existing heart conditions;
5. Clinically significant renal disturbance (GFR (MDRD) ≤ 30 mL/min/1.73m2) or known renal disease;
6. Severe inflammatory or current malignant disease;
7. Darkly coloured skin;
8. Auto-immune / connective tissue disease;
9. Aorta dissection;
10. Comatose at admission to the CCU;
11. Undergoing PCI for STEMI as a result of complications during elective procedures.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-okt-2012
- planned closingdate31-mrt-2013
- Target number of participants40
- InterventionsObtainment of blood samples (these repeated procedures will be in alignment with the standard blood sampling as part of standard diagnostic work-up as much as possible).
- Primary outcomeThe 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 outcomeN/A
- TimepointsA blood sample will be taken at hospital arrival and within 0 till 6h after the PCI procedure. Furthermore, follow-up fasting blood samples will be collected at day 2, 3 and 4 after the initial admission, between 8:00am and 10:00am (i.e. 16 till 26h, 40 till50h, and 64 till 74h).
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Erasmus Medical Center (EMC), Department of Cardiology, section Clinical Epidemiology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Rotterdam
- PublicationsN/A
- Brief summaryHigh 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. We aim to observe the kinetics of AGEs in the acute phase of STEMI and first few days after admission for STEMI by repeated measurements with the AGE reader® through skin AF, as well as by determining serum AGEs through repeated blood sampling. Such serial follow-up might reveal relations between AGEs levels and the clinical course of STEMI patients.
- Main changes (audit trail)
- RECORD27-sep-2012 - 18-okt-2012

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