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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual Nitroglycerin spray | Active Comparator | Sublingual Nitroglycerin spray of 0.8 mg |
|
| Sublingual Nitroglycerin tablet | Active Comparator | Sublingual Nitroglycerin tablet of 0.8 mg |
|
| Nitroglycerin skin patch | Active Comparator | Nitroglycerin skin patch of 0.8 mg/h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sublingual Nitroglycerin Spray | Sublingual Nitroglycerin spray of 0.8 mg 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. |
| FG001 | Sublingual Nitroglycerin Tablet | Sublingual Nitroglycerin tablet of 0.8 mg 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. |
| FG002 | Nitroglycerin Skin Patch | Nitroglycerin skin patch of 0.8 mg/h 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sublingual Nitroglycerin Spray | Sublingual Nitroglycerin spray of 0.8 mg 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | Fold change | obtained on the same day (day 0) of nitroglycerine administration (nitroglycerine is administered during the cCTA exam appointment). |
|
From time of nitroglycerin was given until until patients left the Radiology department. Usually 1 hour after the exam.
There were no patients with serious adverse events. There were no patients with all-cause mortality. There were no patients with other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sublingual Nitroglycerin Spray | Sublingual Nitroglycerin spray of 0.8 mg Patients will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. |
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To evaluate coronary diameter change by nitroglycerin administration, non-constrast and contrast ECG-gated images were compared. Measurements avoided areas of visible arteriosclerosis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Ghoshhajra | Massachusetts General Hospital | 617-726-5954 | BGHOSHHAJRA@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2018 | Aug 28, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 23, 2017 | Aug 28, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
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|
| BG001 | Sublingual Nitroglycerin Tablet | Sublingual Nitroglycerin tablet of 0.8 mg 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. |
| BG002 | Nitroglycerin Skin Patch | Nitroglycerin skin patch of 0.8 mg/h 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Coronary diameter | Mean | Standard Deviation | mm |
|
| OG001 | Sublingual Nitroglycerin Tablet | Sublingual Nitroglycerin tablet of 0.8 mg 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. |
| OG002 | Nitroglycerin Skin Patch | Nitroglycerin skin patch of 0.8 mg/h 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. |
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 0 |
| 66 |
| EG001 | Sublingual Nitroglycerin Tablet | Sublingual Nitroglycerin tablet of 0.8 mg Patients will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. | 0 | 66 | 0 | 66 | 0 | 66 |
| EG002 | Nitroglycerin Skin Patch | Nitroglycerin skin patch of 0.8 mg/h Patients categorized to transdermal administration will receive Nitroglycerin after Calcium scoring scan and 1 hour before the cCTA examination. The patch will be placed on the chest or the upper arm. | 0 | 66 | 0 | 66 | 0 | 66 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Male |
|