The primary objectives of the study is to test the hypothesis that in healthy volunteers RIPC (bilateral forearm ischemia and reperfusion) reduces troponin I appearance in plasma in response to a high intensive bicycle exercise test.
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Serum levels of hs-troponin I in response to intensive exercise test.
Secondary outcome
Not applicable
Background summary
We recently confirmed that a standardized, moderately intensive exercise (70
minutes of cycling at 80% of maximal heart rate reserve) in healthy volunteers
induces a rise in plasma troponin I as measured with a highly sensitive Elisa
technique (hs-troponin I; CMO 2010/337). This observation suggests that
intensive exercise challenges the heart sufficiently to induce a mismatch in
oxygen demand and supply resulting in an increase in cardiac troponins,
potentially relating to mild cardiac injury. This opens a new window of
opportunities to study interventions for their efficacy to modulate
ischemia-reperfusion injury. However, the increase was only small and remote
ischemic preconditioning (RIPC) did not affect this small increase
significantly (n=12). Two of these volunteers with the largest increase in
troponin I showed a marked effect of RIPC, reflected by an attenuation of the
exercise-induced increase in troponin I. We hypothesize that the lack of effect
of RIPC is explained by the limited cardiac stress of the exercise protocol
used. Therefore, we propose now to study the effect of a more intense exercise
test on plasma troponin I. Furthermore, we intensify the RIPC stimulus to
further exclude an inadequate RIPC stimulus as a potential explanation for our
negative finding.
Study objective
The primary objectives of the study is to test the hypothesis that in healthy
volunteers RIPC (bilateral forearm ischemia and reperfusion) reduces troponin
I appearance in plasma in response to a high intensive bicycle exercise test.
Study design
Single centre, randomized cross-over trial
Intervention
Maximal bicycle test (to determine maximal heart rate), at least one week later
followed by two intensive bicycle exercise tests per volunteer, separated by at
least 2 weeks. One of these intensive exercise tests will be preceded by
forearm ischemia (three 5-min cycles of bilateral forearm ischaemia, induced by
cuffs placed on both upper arms and simultaneously inflated to 200 mm Hg,
followed by 5 min of reperfusion.
Study burden and risks
Submaximal bicycle exercise tests are safe in healthy volunteers without
hypertension, normal ECG and without signs of cardiovascular disease. In a
previous study (CMO 2010/337), 70 minutes of cycling exercise at 80% of maximal
heart rate reserve appeared to be safe in a similarly selected group of healthy
young individuals. The RIPC protocol that will be used in this study is safe,
based on results from our own studies and observations by other research
groups. This study will provide important data on the feasibility of high
intensive bicycle exercise and subsequent measurement of plasma troponin as a
tool to study cardiac ischemia-reperfusion injury in vivo.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
• Age : 18-45 years
• Willing to sign informed consent
• Healthy
Exclusion criteria
• Hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg)
• Any cardiovascular abnormality in past medical history, physical examination or ECG, including prolonged QTc interval.
• Drug abuse
• Alcohol abuse (> 3 units/day)
• Smoking during the last 2 years
• BMI>=30 kg/m2
• Inability to perform bicycle exercise
• The presence of an absolute or relative contra-indication for exercise testing (table 2)
• The presence of diabetes (fasting glucose > 6.9 mmol/l, non-fasting glucose > 11.0 mmol/l; if non-fasting glucose is > 6.9 mmol/l, blood glucose measurement will be repeated in fasting condition and should then not exceed 6.9 mmol/l.)
• Total cholesterol in blood 6.5 mmol/l or higher
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 | NL37510.091.11 |