To quantify the effect of THL on the laboratory analysis of NEFA in heparinized patients with AMI undergoing primary PCI
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The degree of difference between NEFA levels analyzed in the absence and
presence of THL in the test tube during blood sampling
Secondary outcome
LPL
APTT
Background summary
Dramatic increases in plasma non-esterified fatty acid levels (NEFA) heve been
reported in patients with acute myocardial infarction (AMI). This appears to be
especially so when heparin is used, as in acute percutaneous coronary
interventions (PCI). It has been suggested that very high NEFA levels are
associated with inhibition of myocardial metabolic and mechanical function,
especially following ischemia and reperfusion.
However, it has been demonstrated in healthy volenteers and in patients
undergoing cardiac surgery that NEFA levels may be substantially overestemated
(> 50%). This is probably caused by the occurrence of ongoing lipolysis in the
test-tube (ex-vivo) due to the presence of high levels of lipoprotein lipase
(LPL). Plasma levels of LPL are increased following intravenous administration
of heparin. To prevent the ongoing lipolysis in the test tube, a blocker of LPL
activity has been used. This is tetrahydrolipstatin (THL). To date, the use of
such an LPL blocker in cardiac patients has not been described.
Therefore, we postulate that dramatic elevation of NEFA at early reperfusion
during PCI (to values >> 1 mMol/L), is caused by overestimation. To test our
hypothesis, the present study is designed to quantify the impact of THL on the
laboratory analysis of NEFA in non-diabetic and diabetic patients with ST
segment elevation myocardial infarction (STEMI), undergoing acute percutaneous
coronary interventions (PCI).
Study objective
To quantify the effect of THL on the laboratory analysis of NEFA in heparinized
patients with AMI undergoing primary PCI
Study design
Prospective, non-randomized comparison of two laboratory techniques.
Study burden and risks
1. Three EXTRA venapunctures may be painful and may lead to hematoma.
2. 100 ml of EXTRA blood sampling for the study only (over a period of 28h) may
lead to some drop in hemoglobin levels.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Non-diabetic and diabetic patients with acute myocardial infarction undergoing primary percutaneous coronary angioplasty
Exclusion criteria
Participation in another clinical research study within 30 days of enrollment.
Hemoglobine level < 7 mmol/l prior to start of PCI procedure.
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 | NL21688.018.08 |