NCT02961946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Timeline
Completed

Started Mar 2017

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 17, 2019

Completed
Last Updated

September 17, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

November 3, 2016

Results QC Date

August 3, 2019

Last Update Submit

August 28, 2019

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (3)

Sublingual Nitroglycerin spray

ACTIVE COMPARATOR

Sublingual Nitroglycerin spray of 0.8 mg

Drug: Nitroglycerin

Sublingual Nitroglycerin tablet

ACTIVE COMPARATOR

Sublingual Nitroglycerin tablet of 0.8 mg

Drug: Nitroglycerin

Nitroglycerin skin patch

ACTIVE COMPARATOR

Nitroglycerin skin patch of 0.8 mg/h

Drug: Nitroglycerin

Interventions

NitroglycerinDRUG

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.

Nitroglycerin skin patchSublingual Nitroglycerin spraySublingual Nitroglycerin tablet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled cCTA with contrast.
  • Able to comprehend and sign the consent form.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Nitroglycerin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Nitro CompoundsOrganic Chemicals

Limitations and Caveats

To evaluate coronary diameter change by nitroglycerin administration, non-constrast and contrast ECG-gated images were compared. Measurements avoided areas of visible arteriosclerosis.

Results Point of Contact

Title
Dr. Brian Ghoshhajra
Organization
Massachusetts General Hospital
BGHOSHHAJRA@mgh.harvard.edu
617-726-5954

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2016

First Posted

November 11, 2016

Study Start

March 15, 2017

Primary Completion

October 31, 2017

Study Completion

August 2, 2018

Last Updated

September 17, 2019

Results First Posted

September 17, 2019

Record last verified: 2019-08

Locations

US(1)