Primary Raynaud PhenomenonNCT03815162
Cocoa Flavanol Supplementation in Raynaud's Phenomenon
A study testing High Flavanol Cocoa extract and Alkalised cocoa in people with Primary Raynaud Phenomenon, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The study aims to investigate the effect that supplementing the diet with cocoa flavanols has on vasospasm symptoms and temperature regulation in women with primary Raynaud's phenomenon (PRP). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Raynaud Phenomenon
- What is being tested?
- High Flavanol Cocoa extract and Alkalised cocoa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2018to 31 Jul 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Experience symptoms of Primary Raynaud's Phenomenon, with >1 attack / week through the winter months
- Daily consumption of caffeine containing foods/drinks.
- BMI <27kg/m2
Who cannot join
- pregnant or breast feeding (women only),
- clinically significant metabolic or endocrine abnormalities
- fasting glucose >6.5mmol/l,
- taking Bosentan, aspirin, dipyridamole, heparin or transdermal nitrates,
- herbal supplement use,
- food allergies related to the investigational product (cocoa, peanuts, milk),
Show all 10Show fewer
- sensitivity to methylxanthines (e.g. caffeine, theobromine).
- Presence or history of digital ulceration,
- blood parameters suggesting secondary Raynaud's,
- history of migraines
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
David Greenfield Human Physiology Laboratories
Nottingham, Notts, NG72UH
About this study
Official title: Pilot Study to Investigate the Effect of Cocoa Flavanols on Symptoms in Primary Raynaud's Phenomenon
The study aims to investigate the effect that supplementing the diet with cocoa flavanols has on vasospasm symptoms and temperature regulation in women with primary Raynaud's phenomenon (PRP). Participants will be randomised to consume either high flavanol cocoa extract or low flavanol cocoa (placebo) daily for 3 months.
Read the detailed description
Primary Raynaud's phenomenon (PRP) is characterised by periodic vasospasm of the fingers and toes precipitated by exposure to cold or emotional stimuli and stress. Previous studies have demonstrated that underlying this condition there can be vascular endothelium dysfunction. Pharmacological interventions used to relieve symptoms and complications in PRP include drugs targeted at increasing nitric oxide (NO; transdermal nitrates) levels. Cocoa derived products, rich in the phytonutrients 'flavanols', have been shown to increase the bioavailability of NO at the vascular endothelium and promote vasodilation, which may address an underlying cause of PRP and mitigate symptoms. Previous work carried out in the research group has indicated that the acute consumption of cocoa does not compromise the counter-regulatory responses to localised cold exposure in those with PRP.
30 individuals with PRP will be recruited. Those interested in taking part will attend a medical screening and consent visit. If recruited, a participant number will be assigned to them sequentially and they will be randomised to either experimental or control group, with neither the participants nor the research team knowing which group they have been allocated to. Participants will be asked to complete a diet diary before attending 4 further visits over a period of 3 months.
Visit 1 (pre-intervention) and 4 (end of intervention); immediately on arrival, participants will be asked to lie semi-supine on a hospital bed. Skin temperature (surface thermocouples) and 'core' temperature (infrared tympanic thermometer) will start to be recorded to identify when these parameters have stabilized in room temperature (set at 25oC). Blood pressure will be taken using an arm cuff. Then a Finometer cuff will be attached to the left middle finger to record cardiovascular parameters (Blood pressure /heart rate/ cardiac output) and a laser Doppler probe will be attached to the dorsum of both index fingers to assess skin blood flow. Once the finger skin temperature has remained stable for 6 minutes, baseline Finometer and laser Doppler measurements will be recorded and the skin and 'core' temperature will be noted. Then, the right hand will be placed in a temperature regulated box which is set at an air temperature of 0oC. The hand will be cooled to a finger skin temperature of 15oC, then the box temperature will be modified to maintain the skin temperature at 15oC. The time that it takes for the skin temperature on the fingers to reach 15oC will be recorded. With the finger skin temperature stable at 15oC, Finometer and laser Doppler measurements will be repeated and the 'core' temperature at this point noted. Then, the hand will be removed from the chamber, and allowed to equilibrate in room temperature. The time taken for the skin temperature to reach stability will be recorded, as will the absolute temperature that it stabilises to. Measures above will be repeated once hand temperature is stable. Once these measures have been made, all equipment will be removed and a 15ml blood sample will be taken (for epicatechin, glucose and insulin analysis). The participant will be asked to complete 3 questionnaires (SF-36, Raynaud's symptoms and a food frequency questionnaire). Participants will also return a 4-day diet diary at visits 1 and 4, and their symptom diary at visit 4.
Visits 2 (end of month 1) and 3 (end of month 2); participants will return a 4-day diet diary, symptom diary and any unused capsules. They will also have a resting blood pressure measurement made, weight measured and be asked to complete 3 questionnaires (SF-36, Raynaud's symptoms and a food frequency questionnaire).
At the end of Visits 1, 2 and 3, participants will be given a months' supply of capsules, a symptom diary and a diet diary (to be completed in the week prior to the next visit).
- Conditions
- Primary Raynaud Phenomenon
- Being tested
- High Flavanol Cocoa extract, Alkalised cocoa
- Keywords
- cocoa flavanols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Flavanol Cocoa extractDietary supplement
Experimental group
Alkalised cocoaDietary supplement
Control group
| Study group | Role | What they receive |
|---|---|---|
| High Flavanol Cocoa extract | Experimental | 278mg total flavanols (38.3mg epicatechin) per opaque cellulose capsule 3 capsules consumed once per day (836 mg total flavanols; 115mg epicatechin) for 3 months Receives: Dietary Supplement: High Flavanol Cocoa extract |
| Alkalised cocoa | Placebo comparator | 0mg total flavanols (0mg epicatechin) per opaque cellulose capsule 3 capsules consumed once per day (0mg total flavanols; 0mg epicatechin) for 3 months Receives: Dietary Supplement: Alkalised cocoa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasospasm
frequency of vasospasm
Measured: 3 months
Secondary outcomes (30)
Severity of vasospasm symptoms
visual analogue score for pain associated with each vasospasm occasion. Participants indicate pain intensity by placing a vertical line on a 100mm horizontal line where the start of the line (left-hand side; 0mm) represents 'no pain' and the end of the line (right-hand side; 100mm) represents 'most severe pain'. Distance of the vertical line from 0 provides the visual analogue score. A lower score indicates a more favourable outcome.
Measured: 3 months
Duration of vasospasm symptoms
duration that symptoms persist for on each vasospasm occasion
Measured: 3 months
Raynaud's Condition score
Assessment of Raynaud's symptoms using the validated Raynaud's Condition Score. This is a 1 to 10 Likert scale, with 0 representing 'no difficulty' and 10 indicating 'extreme difficulty' with symptoms; collected daily for 3 months, a lower score indicates a more favourable outcome.
Measured: 3 months
Blood pressure
blood pressure measured by automated oscillometric blood pressure
Measured: pre-intervention
Blood pressure
blood pressure measured by automated oscillometric blood pressure
Measured: 4 weeks after starting intervention
Blood pressure
blood pressure measured by automated oscillometric blood pressure
Measured: 8 weeks after starting intervention
Blood pressure
blood pressure measured by automated oscillometric blood pressure
Measured: 12 weeks after starting the intervention
Dietary polyphenol intake
estimation of dietary polyphenols made by food frequency questionnaire
Measured: pre-intervention
Dietary polyphenol intake
estimation of dietary polyphenols made by food frequency questionnaire
Measured: 4 weeks after starting intervention
Dietary polyphenol intake
estimation of dietary polyphenols made by food frequency questionnaire
Measured: 8 weeks after starting intervention
Dietary polyphenol intake
estimation of dietary polyphenols made by food frequency questionnaire
Measured: 12 weeks after starting the intervention
Ambient skin temperature
skin temperature of a finger exposed to an environmental temperature of 25oC, before cooling
Measured: pre-intervention
Ambient skin temperature
skin temperature of a finger exposed to an environmental temperature of 25oC, before cooling
Measured: 12 weeks after starting the intervention
Ambient skin blood flow
finger blood flow (measured using laser Doppler flowmetry) when exposed to an environmental temperature of 25oC, before cooling
Measured: pre-intervention
Ambient skin blood flow
finger blood flow (measured using laser Doppler flowmetry) when exposed to an environmental temperature of 25oC, before cooling
Measured: 12 weeks after starting the intervention
Skin temperature response to acute cooling
The time taken for skin temperature of the finger to stabilise in response to localised cooling (in an air temperature of 0oC)
Measured: pre-intervention
Skin temperature response to acute cooling
The time taken for skin temperature of the finger to stabilise in response to localised cooling (in an air temperature of 0oC)
Measured: 12 weeks after starting the intervention
Skin blood flow response to acute cooling
Finger Skin blood flow; measurement (using laser Doppler flowmetry) made once finger skin temperature has stabilised in response to localised cooling (in an air temperature of 0oC)
Measured: pre-intervention
Skin blood flow response to acute cooling
Finger Skin blood flow; measurement (using laser Doppler flowmetry) made once finger skin temperature has stabilised in response to localised cooling (in an air temperature of 0oC)
Measured: 12 weeks after starting the intervention
Skin temperature response to re-warming
The time taken for skin temperature of finger to stabilise in an environmental temperature of 25oC following localised cooling (in an air temperature of 0oC)
Measured: pre-intervention
Skin temperature response to re-warming
The time taken for skin temperature of finger to stabilise in an environmental temperature of 25oC following localised cooling (in an air temperature of 0oC)
Measured: 12 weeks after starting the intervention
Skin temperature after re-warming
skin temperature that a finger exposed to an environmental temperature of 25oC stabilises to after localised cooling
Measured: pre-intervention
Skin temperature after re-warming
skin temperature that a finger exposed to an environmental temperature of 25oC stabilises to after localised cooling
Measured: 12 weeks after starting the intervention
Quality of life score
Assessed using SF-36 questionnaire. Responses are coded and normalised to the UK population, as per standard methods, and a score for mental and physical health calculated; a higher score indicating a more favourable outcome
Measured: pre-intervention
Quality of life score
Assessed using SF-36 questionnaire. Responses are coded and normalised to the UK population, as per standard methods, and a score for mental and physical health calculated; a higher score indicating a more favourable outcome
Measured: 4 weeks after starting intervention
Quality of life score
Assessed using SF-36 questionnaire. Responses are coded and normalised to the UK population, as per standard methods, and a score for mental and physical health calculated; a higher score indicating a more favourable outcome
Measured: 8 weeks after starting intervention
Quality of life score
Assessed using SF-36 questionnaire. Responses are coded and normalised to the UK population, as per standard methods, and a score for mental and physical health calculated; a higher score indicating a more favourable outcome
Measured: 12 weeks after starting the intervention
Attrition rate
Number of participants completing the protocol as a proportion of those who were randomised to the study
Measured: 2 years
Adverse events
Any injury, accident or illness experienced over the intervention period will be documented
Measured: 3 months
Recruitment rate
number of people volunteering to take part in the study as a proportion of those expressing initial interest
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start16 Oct 2018
- Primary completion30 Apr 2020
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Raynaud PhenomenonStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, placebo controlled study. Block randomised with equal allocation of participants between groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Simpson, University of Nottingham
- Investigators
- Ian A Macdonald, PhD, Study director, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815162
- Sponsor's protocol ID
- 112-1809
- Status last verified
- Nov 2021
- First submitted
- 18 Jan 2019
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared with other researchers
Publications
Herrick A. Raynaud's phenomenon. Curr Treat Options Cardiovasc Med. 2008 Apr;10(2):146-55. doi: 10.1007/s11936-008-0016-y.
PubMed 18325317Chung L, Shapiro L, Fiorentino D, Baron M, Shanahan J, Sule S, Hsu V, Rothfield N, Steen V, Martin RW, Smith E, Mayes M, Simms R, Pope J, Kahaleh B, Csuka ME, Gruber B, Collier D, Sweiss N, Gilbert A, Dechow FJ, Gregory J, Wigley FM. MQX-503, a novel formulation of nitroglycerin, improves the severity of Raynaud's phenomenon: a randomized, controlled trial. Arthritis Rheum. 2009 Mar;60(3):870-7. doi: 10.1002/art.24351.
PubMed 19248104
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Effect of Cocoa Flavanols on Symptoms in Primary Raynaud's Phenomenon
- ClinicalTrials.gov ID
- NCT03815162
- Acronym / sponsor ID
- 112-1809
- Conditions
- Primary Raynaud Phenomenon
- Keywords
- cocoa flavanols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 24 Jan 2019 (actual)
- 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.
The study aims to investigate the effect that supplementing the diet with cocoa flavanols has on vasospasm symptoms and temperature regulation in women with primary Raynaud's phenomenon (PRP). Participants will be randomised to consume either high flavanol cocoa extract or low flavanol cocoa (placebo) daily for 3 months.
Detailed description
Primary Raynaud's phenomenon (PRP) is characterised by periodic vasospasm of the fingers and toes precipitated by exposure to cold or emotional stimuli and stress. Previous studies have demonstrated that underlying this condition there can be vascular endothelium dysfunction. Pharmacological interventions used to relieve symptoms and complications in PRP include drugs targeted at increasing nitric oxide (NO; transdermal nitrates) levels. Cocoa derived products, rich in the phytonutrients 'flavanols', have been shown to increase the bioavailability of NO at the vascular endothelium and promote vasodilation, which may address an underlying cause of PRP and mitigate symptoms. Previous work carried out in the research group has indicated that the acute consumption of cocoa does not compromise the counter-regulatory responses to localised cold exposure in those with PRP.
30 individuals with PRP will be recruited. Those interested in taking part will attend a medical screening and consent visit. If recruited, a participant number will be assigned to them sequentially and they will be randomised to either experimental or control group, with neither the participants nor the research team knowing which group they have been allocated to. Participants will be asked to complete a diet diary before attending 4 further visits over a period of 3 months.
Visit 1 (pre-intervention) and 4 (end of intervention); immediately on arrival, participants will be asked to lie semi-supine on a hospital bed. Skin temperature (surface thermocouples) and 'core' temperature (infrared tympanic thermometer) will start to be recorded to identify when these parameters have stabilized in room temperature (set at 25oC). Blood pressure will be taken using an arm cuff. Then a Finometer cuff will be attached to the left middle finger to record cardiovascular parameters (Blood pressure /heart rate/ cardiac output) and a laser Doppler probe will be attached to the dorsum of both index fingers to assess skin blood flow. Once the finger skin temperature has remained stable for 6 minutes, baseline Finometer and laser Doppler measurements will be recorded and the skin and 'core' temperature will be noted. Then, the right hand will be placed in a temperature regulated box which is set at an air temperature of 0oC. The hand will be cooled to a finger skin temperature of 15oC, then the box temperature will be modified to maintain the skin temperature at 15oC. The time that it takes for the skin temperature on the fingers to reach 15oC will be recorded. With the finger skin temperature stable at 15oC, Finometer and laser Doppler measurements will be repeated and the 'core' temperature at this point noted. Then, the hand will be removed from the chamber, and allowed to equilibrate in room temperature. The time taken for the skin temperature to reach stability will be recorded, as will the absolute temperature that it stabilises to. Measures above will be repeated once hand temperature is stable. Once these measures have been made, all equipment will be removed and a 15ml blood sample will be taken (for epicatechin, glucose and insulin analysis). The participant will be asked to complete 3 questionnaires (SF-36, Raynaud's symptoms and a food frequency questionnaire). Participants will also return a 4-day diet diary at visits 1 and 4, and their symptom diary at visit 4.
Visits 2 (end of month 1) and 3 (end of month 2); participants will return a 4-day diet diary, symptom diary and any unused capsules. They will also have a resting blood pressure measurement made, weight measured and be asked to complete 3 questionnaires (SF-36, Raynaud's symptoms and a food frequency questionnaire).
At the end of Visits 1, 2 and 3, participants will be given a months' supply of capsules, a symptom diary and a diet diary (to be completed in the week prior to the next visit).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded, placebo controlled study. Block randomised with equal allocation of participants between groups.
| Arm | Type | Receives |
|---|---|---|
| High Flavanol Cocoa extract | Experimental | Dietary Supplement: High Flavanol Cocoa extract278mg total flavanols (38.3mg epicatechin) per opaque cellulose capsule 3 capsules consumed once per day (836 mg total flavanols; 115mg epicatechin) for 3 months |
| Alkalised cocoa | Placebo comparator | Dietary Supplement: Alkalised cocoa0mg total flavanols (0mg epicatechin) per opaque cellulose capsule 3 capsules consumed once per day (0mg total flavanols; 0mg epicatechin) for 3 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Experience symptoms of Primary Raynaud's Phenomenon, with >1 attack / week through the winter months
- Daily consumption of caffeine containing foods/drinks.
- BMI <27kg/m2
Key exclusion criteria (10 listed)
- pregnant or breast feeding (women only),
- clinically significant metabolic or endocrine abnormalities
- fasting glucose >6.5mmol/l,
- taking Bosentan, aspirin, dipyridamole, heparin or transdermal nitrates,
- herbal supplement use,
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 |
|---|---|---|
| High Flavanol Cocoa extractExperimental group | Dietary supplement | High Flavanol Cocoa extract |
| Alkalised cocoaControl group | Dietary supplement | Alkalised cocoa |
Primary outcome
Vasospasm
Time frame: 3 months
frequency of vasospasm
30 secondary outcomes
Severity of vasospasm symptoms
Time frame: 3 months
Duration of vasospasm symptoms
Time frame: 3 months
Raynaud's Condition score
Time frame: 3 months
Blood pressure
Time frame: pre-intervention
Blood pressure
Time frame: 4 weeks after starting intervention
Blood pressure
Time frame: 8 weeks after starting intervention
Blood pressure
Time frame: 12 weeks after starting the intervention
Dietary polyphenol intake
Time frame: pre-intervention
Dietary polyphenol intake
Time frame: 4 weeks after starting intervention
Dietary polyphenol intake
Time frame: 8 weeks after starting intervention
Dietary polyphenol intake
Time frame: 12 weeks after starting the intervention
Ambient skin temperature
Time frame: pre-intervention
Ambient skin temperature
Time frame: 12 weeks after starting the intervention
Ambient skin blood flow
Time frame: pre-intervention
Ambient skin blood flow
Time frame: 12 weeks after starting the intervention
Skin temperature response to acute cooling
Time frame: pre-intervention
Skin temperature response to acute cooling
Time frame: 12 weeks after starting the intervention
Skin blood flow response to acute cooling
Time frame: pre-intervention
Skin blood flow response to acute cooling
Time frame: 12 weeks after starting the intervention
Skin temperature response to re-warming
Time frame: pre-intervention
Skin temperature response to re-warming
Time frame: 12 weeks after starting the intervention
Skin temperature after re-warming
Time frame: pre-intervention
Skin temperature after re-warming
Time frame: 12 weeks after starting the intervention
Quality of life score
Time frame: pre-intervention
Quality of life score
Time frame: 4 weeks after starting intervention
Quality of life score
Time frame: 8 weeks after starting intervention
Quality of life score
Time frame: 12 weeks after starting the intervention
Attrition rate
Time frame: 2 years
Adverse events
Time frame: 3 months
Recruitment rate
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Background: PubMed 18325317Herrick A. Raynaud's phenomenon. Curr Treat Options Cardiovasc Med. 2008 Apr;10(2):146-55. doi: 10.1007/s11936-008-0016-y.
- Background: PubMed 19248104Chung L, Shapiro L, Fiorentino D, Baron M, Shanahan J, Sule S, Hsu V, Rothfield N, Steen V, Martin RW, Smith E, Mayes M, Simms R, Pope J, Kahaleh B, Csuka ME, Gruber B, Collier D, Sweiss N, Gilbert A, Dechow FJ, Gregory J, Wigley FM. MQX-503, a novel formulation of nitroglycerin, improves the severity of Raynaud's phenomenon: a randomized, controlled trial. Arthritis Rheum. 2009 Mar;60(3):870-7. doi: 10.1002/art.24351.
- Individual participant dataSharing planned: No. Individual data will not be shared with other researchers
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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.
Ian A Macdonald, PhD study director
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flavanol Cocoa extract and Alkalised cocoa in people with Primary Raynaud Phenomenon, run by University of Nottingham 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 4 Nov 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vasospasm (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815162, which also lists 2 linked publications.
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 4 Nov 2021.