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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitroglycerin

Drug

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.

Primary outcomes

Coronary Artery Diameter Change

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Nov 11, 2016
Registry last updated: Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed