Coronary Artery Disease
Conditions
Brief summary
To evaluate image quality of coronary CT angiography (cCTA) after sublingual and transdermal administration of Nitroglycerin. Aim of this prospective research study is to investigate equivalence on image quality after sublingual or transdermal Nitroglycerin administration (H0). Furthermore, the feasibility of transdermal Nitroglycerin administration will be evaluated.
Interventions
DRUGNitroglycerin
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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Scheduled cCTA with contrast. 2. Able to comprehend and sign the consent form.
Exclusion criteria
1. Known hypersensitivity to glyceryl trinitrate, and related organic nitrates. 2. Acute circulatory failure associated with marked hypotension (shock). 3. Conditions associated with elevated intracranial pressure, cerebral haemorrhage and head trauma. 4. Closed-angle glaucoma. 5. Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra®), tadalafil (Cialis), or vardenafil (Levitra) within the last 24 hours 6. Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias) 7. Critical aortic stenosis 8. Systolic blood pressure \< 90 mmHg 9. Pregnant or lactating female; premenopausal women with a positive urine pregnancy test. 10. Age under 18 11. Unwilling or unable to inform consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary Artery Diameter Change | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 66 |
| 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. | 66 |
| 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. | 66 |
| Total | 198 |
Baseline characteristics
| Characteristic | Sublingual Nitroglycerin Spray | Sublingual Nitroglycerin Tablet | Nitroglycerin Skin Patch | Total |
|---|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 13 | 58 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 13 |
| Coronary diameter | 3.3 mm STANDARD_DEVIATION 0.9 | 3.5 mm STANDARD_DEVIATION 1 | 3.4 mm STANDARD_DEVIATION 1 | 3.4 mm STANDARD_DEVIATION 1 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 32 Participants | 24 Participants | 35 Participants | 91 Participants |
| Sex: Female, Male Male | 34 Participants | 42 Participants | 31 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 | 0 / 66 |
| other Total, other adverse events | 0 / 66 | 0 / 66 | 0 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 | 0 / 66 |
Outcome results
Primary
Coronary Artery Diameter Change
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.
Time frame: obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Sublingual Nitroglycerin Spray | Coronary Artery Diameter Change | 1.14 Fold change |
| Sublingual Nitroglycerin Tablet | Coronary Artery Diameter Change | 1.13 Fold change |
| Nitroglycerin Skin Patch | Coronary Artery Diameter Change | 1.15 Fold change |