Back to resultsEffects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nitroglycerin
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Sublingual Nitroglycerin spray
Sublingual Nitroglycerin tablet
Nitroglycerin skin patch
Arm Description
Sublingual Nitroglycerin spray of 0.8 mg
Sublingual Nitroglycerin tablet of 0.8 mg
Nitroglycerin skin patch of 0.8 mg/h
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02961946
First Posted
November 3, 2016
Last Updated
August 28, 2019
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02961946
Brief Title
Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality
Official Title
Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
August 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sublingual Nitroglycerin spray
Arm Type
Active Comparator
Arm Description
Sublingual Nitroglycerin spray of 0.8 mg
Arm Title
Sublingual Nitroglycerin tablet
Arm Type
Active Comparator
Arm Description
Sublingual Nitroglycerin tablet of 0.8 mg
Arm Title
Nitroglycerin skin patch
Arm Type
Active Comparator
Arm Description
Nitroglycerin skin patch of 0.8 mg/h
Intervention Type
Drug
Intervention Name(s)
Nitroglycerin
Intervention Description
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 Outcome Measure Information:
Title
Coronary Artery Diameter Change
Description
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.
Time Frame
obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Sublingual and Transdermal Administration of Nitroglycerin for Coronary CT Angiography on Image Quality
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