Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Nitroglycerin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled cCTA with contrast. Able to comprehend and sign the consent form. Exclusion Criteria: Known hypersensitivity to glyceryl trinitrate, and related organic nitrates. Acute circulatory failure associated with marked hypotension (shock). Conditions associated with elevated intracranial pressure, cerebral haemorrhage and head trauma. Closed-angle glaucoma. Phosphodiesterase type 5 (PDE5) inhibitors such as sildenafil (Viagra®), tadalafil (Cialis), or vardenafil (Levitra) within the last 24 hours Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias) Critical aortic stenosis Systolic blood pressure < 90 mmHg Pregnant or lactating female; premenopausal women with a positive urine pregnancy test. Age under 18 Unwilling or unable to inform consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sublingual Nitroglycerin spray<br>Sublingual Nitroglycerin spray of 0.8 mg | Drug: Nitroglycerin<br>* 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.<br>|
| Active Comparator: Sublingual Nitroglycerin tablet<br>Sublingual Nitroglycerin tablet of 0.8 mg | Drug: Nitroglycerin<br>* 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.<br>|
| Active Comparator: Nitroglycerin skin patch<br>Nitroglycerin skin patch of 0.8 mg/h | Drug: Nitroglycerin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment). |