Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise

Cardiovascular Disease Clinical Trial

Official title:

Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00441714
• Other study ID #: IPost
• Status: Withdrawn
• Phase: N/A
• First received: February 28, 2007
• Last updated: November 9, 2015
• Start date: October 2007
• Est. completion date: December 2007

Study information

• Verified date: November 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

To adjust our forearm model for ischemia reperfusion injury, in order to used it for assessment of ischemia reperfusion damage in elderly and patients.

To test the effect of ischemic postconditioning on ischemia reperfusion injury in healthy volunteers, using Annexin binding after repetitive handgripping.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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 (random total cholesterol > 6.5 mmol/l)

• Hypertension (supine SBP/DBP > 140/90 mmHg at screening)

• Any cardiovascular disease

• Drug abuse

• Concomitant 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Ischemia-reperfusion Injury
• Postconditioning
• Reperfusion Injury

Intervention

Procedure:
• repetitive short ischemia and reperfusion of non dominant fore arm after 10 minute ischemic exercise

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. Epub 2004 Dec 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annexin A 5 targeting in the non dominant thenar muscle after (ischemic exercise), as a indicator for ischemia reperfusion injury.
Secondary	Workload during (ischemic) exercise.