Coronary AngiographyNCT03576456
Sedative Premedication in Coronary Angiography
A study testing Alprazolam 0.5 mg in people with Coronary Angiography and Sedative Premedication, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Angiography, Sedative Premedication
- What is being tested?
- Alprazolam 0.5 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2019to 1 Aug 2020
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective coronary angiography
Who cannot join
- planned PCI
- use of sedative medication at home
- use of alcohol
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Adriaan Wilgenhof
Brussels, Jette, 1090
Adriaan Wilgenhof, MD, 003224776009, adriaan.wilgenhof@gmail.com
Xavier Galloo, MD, 003224776009
About this study
Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety.
Read the detailed description
Coronary angiography is an invasive procedure that can cause patient discomfort. Sedative premedication before coronary angiography could be used to reduce anxiety and pain, but evidence is lacking. Previous trials were predominantly conducted in men and in coronary interventions with femoral access. Recently, radial access has become the preferred route for performing coronary angiograms (RIVAL trial) In this setting, sedative premedication could be of interest to reduce radial spasms, patient anxiety and pain.
- Conditions
- Coronary Angiography, Sedative Premedication
- Being tested
- Alprazolam 0.5 mg, Placebo Oral Tablet
- Keywords
- coronary angiography, premedication, pain, anxiety
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alprazolam 0.5 mgDrug
receive alprazolam prior to angio
Placebo Oral TabletDrug
receive placebo prior to angio
| Study group | Role | What they receive |
|---|---|---|
| Alprazolam | Active comparator | Patients receive alprazolam 0.5 mg 1 hour prior to coronary angiography. Receives: Drug: Alprazolam 0.5 mg |
| Placebo Oral Tablet | Placebo comparator | Patients receive placebo 1 hour prior to coronary angiography. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
preprocedural anxiety: visual analogue scale
anxiety prior to coronary angiography. Assessed before the procedure through a visual analogue scale for anxiety (VAS-A). The VAS is a visual scale ranging from 0 to 100 with 0 begin no anxiety at all and 100 begin extreme anxiety.
Measured: Assessed before the coronary angiography
periprocedural pain: visual analogue scale
pain during to coronary angiography. Assessed after the procedure through a visual analogue scale for pain. The VAS scale is a visual scale ranging from 0 (no pain) to 100 (extreme pain).
Measured: Assessed after the coronary angiography, within 4 hours.
Secondary outcomes (2)
radial spasm
spasm of the radial artery as experienced by operator. There is no precise measurement up until today.
Measured: during procedure
vascular site access complication
need to switch to femoral access, assessed by the operator.
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo controlled, double blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilgenhof Adriaan, Universitair Ziekenhuis Brussel
- Investigators
- Danny Schoors, MD PhD, Study director, Head of service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576456
- Sponsor's protocol ID
- awxg2018
- Status last verified
- Oct 2018
- First submitted
- 18 Jun 2018
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedative Premedication in Coronary Angiography
- ClinicalTrials.gov ID
- NCT03576456
- Acronym / sponsor ID
- awxg2018
- Conditions
- Coronary Angiography, Sedative Premedication
- Keywords
- coronary angiography, premedication, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 3 Jul 2018 (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.
Evaluation of the possible positive effect of sedative premedication prior to coronary angiography in regards to pain and anxiety.
Detailed description
Coronary angiography is an invasive procedure that can cause patient discomfort. Sedative premedication before coronary angiography could be used to reduce anxiety and pain, but evidence is lacking. Previous trials were predominantly conducted in men and in coronary interventions with femoral access. Recently, radial access has become the preferred route for performing coronary angiograms (RIVAL trial) In this setting, sedative premedication could be of interest to reduce radial spasms, patient anxiety and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo controlled, double blind
| Arm | Type | Receives |
|---|---|---|
| Alprazolam | Active comparator | Drug: Alprazolam 0.5 mgPatients receive alprazolam 0.5 mg 1 hour prior to coronary angiography. |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletPatients receive placebo 1 hour prior to coronary angiography. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective coronary angiography
Key exclusion criteria (3 listed)
- planned PCI
- use of sedative medication at home
- use of alcohol
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 |
|---|---|---|
| Alprazolam 0.5 mgreceive alprazolam prior to angio | Drug | Alprazolam |
| Placebo Oral Tabletreceive placebo prior to angio | Drug | Placebo Oral Tablet |
Primary outcome
preprocedural anxiety: visual analogue scale
Time frame: Assessed before the coronary angiography
anxiety prior to coronary angiography. Assessed before the procedure through a visual analogue scale for anxiety (VAS-A). The VAS is a visual scale ranging from 0 to 100 with 0 begin no anxiety at all and 100 begin extreme anxiety.
periprocedural pain: visual analogue scale
Time frame: Assessed after the coronary angiography, within 4 hours.
pain during to coronary angiography. Assessed after the procedure through a visual analogue scale for pain. The VAS scale is a visual scale ranging from 0 (no pain) to 100 (extreme pain).
2 secondary outcomes
radial spasm
Time frame: during procedure
vascular site access complication
Time frame: during procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Individual participant dataSharing planned: Yes
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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.
Danny Schoors, MD PhD study director
Head of service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alprazolam 0.5 mg in people with Coronary Angiography and Sedative Premedication, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 3 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: status not confirmed, as of the sponsor's last update on 12 Oct 2018. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adriaan Wilgenhof, MD (003224776009, adriaan.wilgenhof@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
preprocedural anxiety: visual analogue scale (time frame: Assessed before the coronary angiography). The study lists 2 primary outcomes in all. 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 12 Oct 2018.