Vasospasm;PeripheralEarly Phase 1NCT05625503
Dilution of Verapamil During Intraarterial Administration
A Early Phase 1 study testing Verapamil and Nicardipine in people with Vasospasm;Peripheral and Burning, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasospasm;Peripheral, Burning, Pain
- What is being tested?
- Verapamil and Nicardipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2022to 1 Dec 2023
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English Speaking patients who are age 18 or older
- Patient must be able to provide own consent and communicate with staff
- Patient's undergoing transradial access (TRA) for the left heart catheterization (LHC)
Who cannot join
- Intubated or sedated patients
- Agitated patients requiring moderate sedation prior to TRA
- Patient's undergoing femoral access for the LHC
- Non-English speaking patients
- Contraindications to Verapamil or Nicardipine: including allergies to these medications, hypotension (mean arterial pressure <65), Bradycardia (heart rate<40)
- Emergent cardiac catheterization
- Inability to obtain radial artery access
- Conversion to radial artery access from another access site
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Hospital
Chicago, Illinois, 60612
About this study
Official title: Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?
This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups:
- Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
- Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL)
The investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms.
- Conditions
- Vasospasm;Peripheral, Burning, Pain
- Being tested
- Verapamil, Nicardipine
- Keywords
- cardiac catheterization, intra-arterial calcium channel blockers, radial artery spasm
- Medical subject headings
- Paresthesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
Also called Calcium channel blocker
All patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography.
NicardipineDrug
Calcium channel blocker
| Study group | Role | What they receive |
|---|---|---|
| Verapamil | Active comparator | Intra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline Receives: Drug: Verapamil |
| Nicardipine | Placebo comparator | Intra-arterial Nicardipine 400 mcg undiluted (8mL) Receives: Drug: Nicardipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radial Artery Spasm
The investigators will document the presence or absence of radial artery spasms with either 0,1, or 2. 0 will indicate no radial artery spasms. 1 will indicate radial artery spasms that did not require a change in strategy. 2 will indicate radial artery spasms that required a change in strategy such as alternate access.
Measured: approximately 30 minutes
Pain Prior to Intra-arterial Calcium Channel Blocker Administration
Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10).
Measured: 30 seconds prior to administration
Pain After Intra-arterial Calcium Channel Blocker Administration
Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10).
Measured: 30 seconds post administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start13 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vasospasm;PeripheralStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalil Ibrahim, University of Illinois Chicago
- Investigators
- Khalil Ibrahim, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625503
- Sponsor's protocol ID
- 2022-0722
- Status last verified
- Nov 2024
- First submitted
- 11 Nov 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Patel K, Duckett M, Vidovich MI, Ibrahim K. Intra-arterial nicardipine versus verapamil during transradial access coronary catheterization. Cardiovasc Revasc Med. 2025 May;74:40-44. doi: 10.1016/j.carrev.2024.08.008. Epub 2024 Aug 20.
PubMed 39191616
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dilution of Verapamil With Normal Saline or Blood Reduce Discomfort Felt During Intraarterial Administration?
- ClinicalTrials.gov ID
- NCT05625503
- Acronym / sponsor ID
- 2022-0722
- Conditions
- Vasospasm;Peripheral, Burning, Pain
- Keywords
- cardiac catheterization, intra-arterial calcium channel blockers, radial artery spasm
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 23 Nov 2022 (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.
This study will be a randomized, single-blind, prospective trial designed to evaluate the efficacy and safety of intra-arterial (IA) Verapamil diluted with normal saline compared to undiluted IA Nicardipine during transradial access (TRA) for percutaneous coronary angiography. Patients who are 18 years or older and undergoing non-emergent percutaneous coronary angiography via TRA will be included. Patients who are non-English speaking, pregnant, or intubated will be excluded. Patients will be randomized to one of the two following groups:
- Group 1 will receive IA Verapamil 5 mg (2mL) diluted with 8 mL of normal saline
- Group 2 will receive IA Nicardipine 400 mcg (undiluted, 8 mL)
The investigators will document the patient's level of discomfort on the Visual Analogue Scale 30 seconds before and after administration of IA Verapamil/Nicardipine. The investigators will also document the presence of radial artery spasms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verapamil | Active comparator | Drug: VerapamilIntra-arterial Verapamil 5 mg (2mL) diluted with 8 mL of normal saline |
| Nicardipine | Placebo comparator | Drug: NicardipineIntra-arterial Nicardipine 400 mcg undiluted (8mL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English Speaking patients who are age 18 or older
- Patient must be able to provide own consent and communicate with staff
- Patient's undergoing transradial access (TRA) for the left heart catheterization (LHC)
Key exclusion criteria (8 listed)
- Intubated or sedated patients
- Agitated patients requiring moderate sedation prior to TRA
- Patient's undergoing femoral access for the LHC
- Non-English speaking patients
- Contraindications to Verapamil or Nicardipine: including allergies to these medications, hypotension (mean arterial pressure <65), Bradycardia (heart rate<40)
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 |
|---|---|---|
| VerapamilAlso: Calcium channel blockerAll patients routinely receive intra-arterial calcium channel blockers during transradial access for coronary angiography. | Drug | Verapamil |
| NicardipineCalcium channel blocker | Drug | Nicardipine |
Primary outcome
Radial Artery Spasm
Time frame: approximately 30 minutes
The investigators will document the presence or absence of radial artery spasms with either 0,1, or 2. 0 will indicate no radial artery spasms. 1 will indicate radial artery spasms that did not require a change in strategy. 2 will indicate radial artery spasms that required a change in strategy such as alternate access.
Pain Prior to Intra-arterial Calcium Channel Blocker Administration
Time frame: 30 seconds prior to administration
Pain prior to intra-arterial calcium channel blocker administration will be assessed through the Visual Analogue Pain scale (from 0 to 10).
Pain After Intra-arterial Calcium Channel Blocker Administration
Time frame: 30 seconds post administration
Pain after intra-arterial calcium channel blocker administration will be assessed through the Visual analogue Pain Scale (from 0 to 10).
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 27 Nov 2024.
- Derived from this study: PubMed 39191616Patel K, Duckett M, Vidovich MI, Ibrahim K. Intra-arterial nicardipine versus verapamil during transradial access coronary catheterization. Cardiovasc Revasc Med. 2025 May;74:40-44. doi: 10.1016/j.carrev.2024.08.008. Epub 2024 Aug 20.
- Individual participant dataSharing planned: Undecided
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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.
Khalil Ibrahim, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Verapamil and Nicardipine in people with Vasospasm;Peripheral and Burning, run by University of Illinois Chicago at 1 site in United States.
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 8 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 27 Nov 2024. 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 States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Radial Artery Spasm (time frame: approximately 30 minutes). The study lists 3 primary outcomes in all. 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 NCT05625503, which also lists 1 linked publication.
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 27 Nov 2024.