Condition category
Circulatory System
Date applied
06/05/2014
Date assigned
22/05/2014
Last edited
22/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cardiovascular events such as heart attacks and strokes are the main cause of illness and death in western countries. Remote ischemic preconditioning (RIPC) is a feasible and practical method to protect the heart against damage after surgery. It is produced by repeated short periods of oxygen interruption using a blood pressure cuff at the upper arm. Serum is the part of blood that is like water and that contains substances (called antibodies) that fight disease. The aim of this study is to find out whether serum taken from male volunteers that underwent this procedure can protect certain cells from a artificially induced absence of oxygen.

Who can participate?
Healthy male volunteers, age 18-45 years.

What does the study involve?
For the remote ischaemic conditioning stimulus, a pressure cuff will be placed on the upper arm and inflated for 5 minutes. Pressure will be released during 5 minutes, after which the cycle will be repeated three more times for a total of four cycles. Blood samples will be taken at three different time points and the blood will be used in the laboratory for further investigations.

What are the possible benefits and risks of participating?
There are no direct benefits or risks for the volunteer. Remote ischaemic conditioning is in itself a safe intervention. Volunteers can experience slight discomfort during inflation of the tourniquet around their upper arm. Blood withdrawal can also give a slight discomfort but is without risk for the volunteer.

Where is the study run from?
Academic Medical Centre (AMC) (Netherlands).

When is the study starting and how long is it expected to run for?
The study ran from June to August 2012.

Who is funding the study?
Academic Medical Centre (AMC) (Netherlands).

Who is the main contact?
Prof Benedikt Preckel

Trial website

Contact information

Type

Scientific

Primary contact

Prof Benedikt Preckel

ORCID ID

Contact details

Department of Anesthesiology
Academic Medical Center
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NL38188.018.11

Study information

Scientific title

Mechanisms of Remote Ischemic PreConditioning in humans: prevention of cellular damage by serum collected after remote conditioning of the upper arm of human male volunteers

Acronym

Me-RIPC

Study hypothesis

We hypothesize that serum taken from volunteers subjected to remote ischemic conditioning of the upper arm can protect different human umbilical vein endothelial cells from hypoxia-reperfusion induced damage. If we find protection we aim to investigate the underlying mechanism of this protection in the in vitro model.

Ethics approval

Medical Ethics Committee of the Academic Medical Center in Amsterdam, 12/01/2012, METC Number: 2012_014, ABR Number: NL38188.018.11

Study design

Researcher blinded study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Myocardial infarction, endothelial disease

Intervention

On the day of participation, a physical examination (cardiopulmonary system) will be performed by a physician prior to the start of the investigational intervention.

The investigational intervention is a remote ischaemic conditioning stimulus. Hereto, a pressure cuff will be placed on the upper arm and inflated to 200 mmHg for 5 minutes. Then, pressure will be released during 5 minutes allowing reperfusion, after which the cycle will be repeated three more times for a total of four cycles. The stimulus will be applied five minutes after T0 blood sampling. Five- and sixty minutes after completion of Remote Ischaemic Conditioning stimulus, T1 and T2 blood will be sampled. Each blood withdrawal will be taken by a separate venous puncture performed by a physician with extensive experience in this field.

For each experiment 100 µl serum per 6-well is needed. The experiment will be repeated three times for each cell type. 45% of the blood withdrawn is hematocrit, thus per time point 22cc blood will be sampled, after centrifugation (to separate cells from the serum) approximately 12cc serum will be left to do the in vitro experiments. In total, the volunteer gives 66cc blood. Samples will not be stored for purposes other than completion of the in vitro experiments.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Lactate dehydrogenase enzyme (LDH) release in human umbilical vein endothelial cells measured at different time points in our in vitro model after incubation with the serum.

Secondary outcome measures

1. We measured mitogen activated protein kinase ERK 1/2, protein kinase B (AKT) and hypoxia inducible factor (HIF) 1 alpha in the endothelial cells by the use of western blotting at time point T0 before remote preconditioning and T1 (after 45 minutes, directly after the remote conditioning protocol).
2. We measured human vascular endothelial growth factor in the plasma of the volunteers also at T0 and T1.

Overall trial start date

15/06/2012

Overall trial end date

28/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy male volunteers aged 18-45 years.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

10

Participant exclusion criteria

1. Any cardiovascular, kidney, pulmonary or endocrine diseases
2. Alcohol or drug abuse
3. No informed consent

Recruitment start date

15/06/2012

Recruitment end date

28/08/2012

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Anesthesiology
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (Netherlands)

Sponsor details

Department of Anesthesiology
Meibergdreef 9
1105 AZ Amsterdam
The Netherlands
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Academic Medical Centre (AMC) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes