1. To adjust and validate our forearm model for ischemia reperfusion injury, in order to used it for assessment of ischemic postconditioning.To adjust our forearm model for ischemia reperfusion injury, in order to used it for assessment of ischemia…
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
Percentage difference in radioactivity (counts/pixel) between experimental and
control thenar muscle at 60 and 240 minutes after reperfusion.
Secondary outcome
Workload during (ischemic) exercise.
Background summary
Recently, ischemic postconditioning has been identified as a protective
intervention against ischemia-reperfusion injury. In animal studies, the
signalling pathway of this (impressive) protective phenomenon is very similar
to ischemic preconditioning. It opens a new avenue of post-reperfusion
interventions with drugs that have been shown to mimic ischemic
preconditioning. Before we can study this phenomenon in our forearm
ischemia-reperfusion model, we need additional validating experiments. The
purpose of this study proposal is to provide these data.
Study objective
1. To adjust and validate our forearm model for ischemia reperfusion injury, in
order to used it for assessment of ischemic postconditioning.
To adjust our forearm model for ischemia reperfusion injury, in order to used
it for assessment of ischemia reperfusion damage in elderly and patients.
2. To test the effect of ischemic postconditioning on ischemia reperfusion
injury in healthy volunteers, using Annexin binding after repetitive
handgripping.
Study design
cross over design
Intervention
Study 1
ischemic exercise vs non-ischemic exercise of the non dominant forearm
Study 2:
10 minute delay between ischemic (exercise) and administration of Annexin A5
and intermittent reperfusion (1 minute reperfusion, 1 minute ischemia, during 8
minutes)
Study burden and risks
This study will be executed at the Clinical Research Centre Nijmegen under
close medical supervision. All medical personnel at the research centre has
been trained in basic life support, including the use of an assisted electric
defibrillator (AED), which is available at the research centre.
Administration of radiolabeled annexin A5 results in an effective dose of less
than 5 mSv, well within the range of accepted exposure to radioactivity for
human research. Participation in this research does not interfere with possible
diagnostic or therapeutic procedures with X-rays of radioactivity in the
future.
Occurrence of an allergic reaction is theoretically possible upon
administration of Annexin A5, however there have been no allergic reaction
reported in all volunteers exposed to Annexin A5.
The volunteers will not benefit directly from participating in this study.
postbus 9101
6500 HB Nijmegen
Nederland
postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
-Male
-Age 18-50 years
-No physical limitation to perform ischemic exercise
-Informed consent
Exclusion criteria
-Diabetes (fasting glucose >7,0mmol/l, or random glucose >11,0mmol/l)
-hyperlipidemia (fasting total cholesterol > 5.5 mmol/l)
-Hypertension (supine SBP/DBP > 140/90 mmHg at screening)
-Any cardiovascular disease
-Drug abuse
-Concomittant chronic use of medication
-Administration of radioactivity in research setting during the last 5 years
-Participation to any drug-investigation during the previous month as checked with VIP check according to CRCN standard procedures.
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 | NL15448.091.06 |