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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Nitroglycerin

• Registration Number: NCT02961946
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Study Start: 2017-03-15
• Primary Completion: 2017-10-31
• Study Completion: 2018-08-02
• Status Verified: 2019-08
• Results First Submitted: 2019-08-03
• Results First Submitted QC: 2019-08-28
• Last Update Submitted: 2019-08-28
• Results First Posted: 2019-09-17
• Last Update Posted: 2019-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sublingual Nitroglycerin spray	Nitroglycerin	Sublingual Nitroglycerin spray of 0.8 mg
Sublingual Nitroglycerin tablet	Nitroglycerin	Sublingual Nitroglycerin tablet of 0.8 mg
Nitroglycerin skin patch	Nitroglycerin	Nitroglycerin skin patch of 0.8 mg/h

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States