Ischaemia-reperfusion (IR) InjuryNCT01075776
The Effects of C-type Natriuretic Peptide on Human Forearm Blood Vessels
A study testing C-type natriuretic peptide (CNP), Saline and Acetylcholine in people with Ischaemia-reperfusion (IR) Injury, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
To determine the effects of whether increasing CNP concentrations slightly above normal will improve the functioning of blood vessels after the interruption in the flow of blood. In this study we are looking at the function of the blood vessels of the forearm, as a substitute for those in the heart Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischaemia-reperfusion (IR) Injury
- What is being tested?
- C-type natriuretic peptide (CNP), Saline and Acetylcholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2020to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy human volunteers on no systemic medication, excepting the oral contraceptive pill
Who cannot join
- History of medical illness
- Unwillingness to sign consent form
- Use of non-OCP medications
- Hypertension on examination of the blood pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of C-type Natriuretic Peptide on Endothelial Function Following Ischaemia-Reperfusion in the Human Forearm
To determine the effects of whether increasing CNP concentrations slightly above normal will improve the functioning of blood vessels after the interruption in the flow of blood. In this study we are looking at the function of the blood vessels of the forearm, as a substitute for those in the heart
- Conditions
- Ischaemia-reperfusion (IR) Injury
- Being tested
- C-type natriuretic peptide (CNP), Saline, Acetylcholine
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-type natriuretic peptide (CNP)Drug
360 pmol/min for 15 minutes intra-arterially
SalineDrug
Sodium Chloride 0.9% intra-arterially 0.5ml/min
AcetylcholineDrug
2 stepped infusions for a total 9min per limb, totalling 1.05micromoles per limb
| Study group | Role | What they receive |
|---|---|---|
| CNP | Experimental | Infusion of CNP prior to IR injury Receives: Drug: C-type natriuretic peptide (CNP); Drug: Acetylcholine |
| Saline | Placebo comparator | Effect of saline infusion prior to IR injury Receives: Drug: Saline; Drug: Acetylcholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in area under curve dose-response to acetylcholine after IR injury
Measured: 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startJan 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischaemia-reperfusion (IR) InjuryStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Amrita Ahluwalia, Queen Mary University of London
- Investigators
- Ahluwalia Amrita, BSc PhD, Principal investigator, Queen Mary University London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075776
- Sponsor's protocol ID
- 007143
- Status last verified
- May 2020
- First submitted
- 23 Feb 2010
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of C-type Natriuretic Peptide on Endothelial Function Following Ischaemia-Reperfusion in the Human Forearm
- ClinicalTrials.gov ID
- NCT01075776
- Acronym / sponsor ID
- 007143
- Conditions
- Ischaemia-reperfusion (IR) Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of whether increasing CNP concentrations slightly above normal will improve the functioning of blood vessels after the interruption in the flow of blood. In this study we are looking at the function of the blood vessels of the forearm, as a substitute for those in the heart
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNP | Experimental | Drug: C-type natriuretic peptide (CNP), Drug: AcetylcholineInfusion of CNP prior to IR injury |
| Saline | Placebo comparator | Drug: Saline, Drug: AcetylcholineEffect of saline infusion prior to IR injury |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy human volunteers on no systemic medication, excepting the oral contraceptive pill
Key exclusion criteria (4 listed)
- History of medical illness
- Unwillingness to sign consent form
- Use of non-OCP medications
- Hypertension on examination of the blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-type natriuretic peptide (CNP)360 pmol/min for 15 minutes intra-arterially | Drug | CNP |
| SalineSodium Chloride 0.9% intra-arterially 0.5ml/min | Drug | Saline |
| Acetylcholine2 stepped infusions for a total 9min per limb, totalling 1.05micromoles per limb | Drug | CNP, Saline |
Primary outcome
Change in area under curve dose-response to acetylcholine after IR injury
Time frame: 2h
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahluwalia Amrita, BSc PhD principal investigator
Queen Mary University London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-type natriuretic peptide (CNP), Saline and Acetylcholine in people with Ischaemia-reperfusion (IR) Injury, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in area under curve dose-response to acetylcholine after IR injury (time frame: 2h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.