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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961946
• Other study ID #: 2016P002417
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2017
• Est. completion date: August 2, 2018

Study information

• Verified date: August 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: August 2, 2018
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment).