Trial Outcomes & Findings for Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality (NCT NCT02961946)
NCT ID: NCT02961946
Last Updated: 2019-09-17
Results Overview
Average diameter of coronary arteries at 7 predefined locations in the proximal, mid, and distal segments of the left main, left anterior descending, left circumflex and right coronary artery. Measurements avoid areas of coronary non-calcified and calcified plaques and measured twice for each location. Proximal and distal deviation from original measurements is possible in case of plaque.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
198 participants
Primary outcome timeframe
obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment).
Results posted on
2019-09-17
Participant Flow
Participant milestones
| Measure |
Sublingual Nitroglycerin Spray
Sublingual Nitroglycerin spray of 0.8 mg
Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
|
Sublingual Nitroglycerin Tablet
Sublingual Nitroglycerin tablet of 0.8 mg
Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
|
Nitroglycerin Skin Patch
Nitroglycerin skin patch of 0.8 mg/h
Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
66
|
|
Overall Study
COMPLETED
|
66
|
66
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
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 |
Sublingual Nitroglycerin Spray
n=66 Participants
Sublingual Nitroglycerin spray of 0.8 mg
Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
|
Sublingual Nitroglycerin Tablet
n=66 Participants
Sublingual Nitroglycerin tablet of 0.8 mg
Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
|
Nitroglycerin Skin Patch
n=66 Participants
Nitroglycerin skin patch of 0.8 mg/h
Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 13 • n=66 Participants
|
58 years
STANDARD_DEVIATION 13 • n=66 Participants
|
57 years
STANDARD_DEVIATION 12 • n=66 Participants
|
58 years
STANDARD_DEVIATION 13 • n=198 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=66 Participants
|
24 Participants
n=66 Participants
|
35 Participants
n=66 Participants
|
91 Participants
n=198 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=66 Participants
|
42 Participants
n=66 Participants
|
31 Participants
n=66 Participants
|
107 Participants
n=198 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Coronary diameter
|
3.3 mm
STANDARD_DEVIATION 0.9 • n=66 Participants
|
3.5 mm
STANDARD_DEVIATION 1.0 • n=66 Participants
|
3.4 mm
STANDARD_DEVIATION 1.0 • n=66 Participants
|
3.4 mm
STANDARD_DEVIATION 1.0 • n=198 Participants
|
PRIMARY outcome
Timeframe: obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment).Average diameter of coronary arteries at 7 predefined locations in the proximal, mid, and distal segments of the left main, left anterior descending, left circumflex and right coronary artery. Measurements avoid areas of coronary non-calcified and calcified plaques and measured twice for each location. Proximal and distal deviation from original measurements is possible in case of plaque.
Outcome measures
| Measure |
Sublingual Nitroglycerin Spray
n=66 Participants
Sublingual Nitroglycerin spray of 0.8 mg
Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
|
Sublingual Nitroglycerin Tablet
n=66 Participants
Sublingual Nitroglycerin tablet of 0.8 mg
Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
|
Nitroglycerin Skin Patch
n=66 Participants
Nitroglycerin skin patch of 0.8 mg/h
Nitroglycerin: Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
|
|---|---|---|---|
|
Coronary Artery Diameter Change
|
1.14 Fold change
Interval 1.12 to 1.15
|
1.13 Fold change
Interval 1.09 to 1.16
|
1.15 Fold change
Interval 1.13 to 1.18
|
Adverse Events
Sublingual Nitroglycerin Spray
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sublingual Nitroglycerin Tablet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nitroglycerin Skin Patch
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