Trial Outcomes & Findings for Radial Artery Vasodilation Heat Study (NCT NCT03620383)
NCT ID: NCT03620383
Last Updated: 2019-09-25
Results Overview
Radial artery cross sectional area after 20 minutes with or without heat application
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
20 minutes after application of topical heat
Results posted on
2019-09-25
Participant Flow
Participant milestones
| Measure |
Heat
Distal topical heat application
Topical Heat: Warm heat pack applied topically in participant hand.
|
No Heat
Inactive heat pack to blind the investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
15
|
|
Overall Study
COMPLETED
|
30
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Heat
n=30 Participants
Distal topical heat application
Topical Heat: Warm heat pack applied topically in participant hand.
|
No Heat
n=15 Participants
Inactive heat pack to blind the investigator.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 10.4 • n=30 Participants
|
34.2 years
STANDARD_DEVIATION 9.3 • n=15 Participants
|
36.5 years
STANDARD_DEVIATION 10.1 • n=45 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=30 Participants
|
5 Participants
n=15 Participants
|
28 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=30 Participants
|
10 Participants
n=15 Participants
|
17 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Baseline radial artery cross sectional area
|
2.5 mm^2
STANDARD_DEVIATION 0.8 • n=30 Participants
|
3.2 mm^2
STANDARD_DEVIATION 1.1 • n=15 Participants
|
2.7 mm^2
STANDARD_DEVIATION 1.0 • n=45 Participants
|
PRIMARY outcome
Timeframe: 20 minutes after application of topical heatRadial artery cross sectional area after 20 minutes with or without heat application
Outcome measures
| Measure |
Heat
n=30 Participants
Distal topical heat application
Topical Heat: Warm heat pack applied topically in participant hand.
|
No Heat
n=15 Participants
Inactive heat pack to blind the investigator.
|
|---|---|---|
|
Radial Artery Cross Sectional Area
|
3.4 mm^2
Standard Deviation 1.3
|
3.0 mm^2
Standard Deviation 1.2
|
Adverse Events
Heat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Heat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place