Mechanisms of remote ischemic preconditioning in humans
| ISRCTN | ISRCTN59201440 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59201440 |
| Secondary identifying numbers | NL38188.018.11 |
- Submission date
- 06/05/2014
- Registration date
- 22/05/2014
- Last edited
- 17/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
Department of Anesthesiology
Academic Medical Center
University of Amsterdam
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Study information
| Study design | Researcher blinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | Me-RIPC |
| Study objectives | 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(s) | Medical Ethics Committee of the Academic Medical Center in Amsterdam, 12/01/2012, METC Number: 2012_014, ABR Number: NL38188.018.11 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/06/2012 |
| Completion date | 28/08/2012 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Male |
| Target number of participants | 10 |
| Key inclusion criteria | Healthy male volunteers aged 18-45 years |
| Key exclusion criteria | 1. Any cardiovascular, kidney, pulmonary or endocrine diseases 2. Alcohol or drug abuse 3. No informed consent |
| Date of first enrolment | 15/06/2012 |
| Date of final enrolment | 28/08/2012 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1105 AZ
Netherlands
Sponsor information
University/education
Department of Anesthesiology
Meibergdreef 9
1105 AZ Amsterdam
The Netherlands
Amsterdam
1105 AZ
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the fact that during the inclusion the trialists did not get informed consent of the volunteers to make the raw data public. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2015 | 17/01/2019 | Yes | No |
Editorial Notes
17/01/2019: Publication reference and IPD sharing statement added.
