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

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT02961946

2016P002417

Details and patient eligibility

About

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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 3 patient groups

Sublingual Nitroglycerin spray

Active Comparator group

Description:

Sublingual Nitroglycerin spray of 0.8 mg

Treatment:

Drug: Nitroglycerin

Sublingual Nitroglycerin tablet

Active Comparator group

Description:

Sublingual Nitroglycerin tablet of 0.8 mg

Treatment:

Drug: Nitroglycerin

Nitroglycerin skin patch

Active Comparator group

Description:

Nitroglycerin skin patch of 0.8 mg/h

Treatment:

Drug: Nitroglycerin