Artery; Dilatation
Conditions
Keywords
cardiac catheterization, transradial approach, nitroglycerin
Brief summary
Phase 1, single-center, open-label clinical study to assess the safety and efficacy of topical nitroglycerin on dilation of the radial artery. Subjects will receive nitroglycerin ointment prior to scheduled PCI and radial artery measurements will be performed to determine mean increase in radial artery diameter at several time points. There will be 20 subjects enrolled in this study.
Detailed description
This is a phase I study evaluating the safety, tolerability, and efficacy of topical nitroglycerin prior to percutaneous coronary intervention (PCI). Although the ultimate plan is to evaluate this intervention vs placebo, it is important to first determine whether topical nitroglycerin not only is safe for patients, but whether it effectively dilates the radial artery. Given that patients who receive topical nitroglycerin applied to the chest for other reasons (angina or acute coronary syndrome, hypertension, etc) have reported headaches and/or have experienced decreased blood pressure, it is important to determine whether these noted side effects are present when nitroglycerin ointment is applied to the arm. Prior to initiating any study procedures, we will perform a Barbeau test to determine normal blood flow through the radial artery and collateral circulation from the ulnar artery through the palmar arch. After the ointment is applied, we will also be measuring the dimensions of the radial artery for the degree of dilation in order to determine whether topical nitroglycerin is indeed a possible method for increasing the rate of PCI performed using the transradial approach (TRA).
Interventions
2 cm (30mg) of 2% nitroglycerin applied 2 cm from the styloid process of the anterior forearm
Sponsors
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory
Exclusion criteria
1. Known nitrate allergy 2. Baseline hypotension with systolic blood pressure \<90mmHg 3. Absence of radial artery blood flow in one or both arms 4. Presence or history of liver, rheumatologic, or chronic kidney disease 5. Current treatment with any vasodilator therapy (eg. Sildenafil) 6. Radial artery catheterization \<30 days prior to enrollment 7. Active site infection 8. AV-fistula or prior radial artery harvest for bypass surgery 9. Abnormal Barbeau test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure | 45 minutes | Changes in blood pressure measured by upper arm cuff pressure |
| Incidence of headache | 45 minutes | Rate and severity of headache, determined by subject-reported symptoms. |
| Hematoma | 45 minutes | Incidence of forearm hematoma development |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radial artery dilation | 45 minutes | Change in radial artery dilation, measured by radial artery diameter using high-frequency (13MHz) linear array transducer 2cm proximal to the radial styloid process at 15 and 30 minute time points. |
| Punctures required | 45 minutes | Number of radial artery punctures/attempts |
| Transradial conversions to transfemoral approach | 45 minutes | Number of conversions to transfemoral approach |
Contacts
Primary ContactMichael W Foster, M.D.
Backup ContactWaqas Ullah, M.D.
Outcome results
None listed