The Effect of Sublingual Nitroglycerin on Absolute Coronary Blood Flow

NCT06823843 | Completed Phase 4

• 1 other identifier: OLV2024/037; B1262024000004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effect of sublingual nitroglycerin on absolute coronary blood flow in adult patients undergoing coronary angiography. The main questions it aims to answer are:

• Does sublingual nitroglycerin change absolute coronary blood flow compared to placebo?
• What is the effect of sublingual nitroglycerin on important cardioavascular parameters such as coronary pressure and resistance? Researchers will compare the sublingual nitroglycerin group to the placebo group to see if nitroglycerin leads to significant changes in coronary blood flow and microvascular function. Participants will:
• Receive either sublingual nitroglycerin or a placebo during coronary angiography.
• Undergo coronary blood flow measurements before and after the intervention using standardized assessment techniques.

Conditions

Coronary Arterial Disease (CAD); Angina (Stable)

Keywords

nitroglycerin (GTN); angina; coronary artery disease; absolute coronary flow; continuous intracoronary thermodilution

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the absolute coronary flow 10 minutes after administration of the intervention

  Absolute coronary flow will be measured using continuous intracoronary thermodilution

  10 minutes from the administration of the sublingual intervention

Secondary Outcomes (7)

• Change from baseline in the absolute microvascular resistance 10 minutes after administration of the intervention

  10 minutes from the administration of the sublingual intervention

• Change from baseline in the absolute epicardial resistance 10 minutes after administration of the intervention

  10 minutes from the administration of the sublingual intervention

• Change from baseline in aortic pressure 10 minutes after administration of the intervention

  10 minutes from the administration of the sublingual intervention

• Change from baseline in distal coronary pressure 10 minutes after administration of the intervention

  10 minutes from the administration of the sublingual intervention

• Change from baseline in left ventricular end-diastolic pressure 10 minutes after administration of the intervention

  10 minutes from the administration of the sublingual intervention

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 puffs of sublingual saline

Drug: Saline (NaCl 0,9 %) (placebo)

GTN

EXPERIMENTAL

2 puffs for a total dose of 800 µg

Drug: Glycerin trinitrate (GTN)

Interventions

Glycerin trinitrate (GTN) DRUG

2 sublingual puffs for a total dose of 800 µg

GTN

Saline (NaCl 0,9 %) (placebo) DRUG

2 puffs of sublingual saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred for invasive coronary angiography (ICA) for suspected coronary artery disease

You may not qualify if:

• ≥1 severe stenosis (defined as a diameter stenosis \>70%)
• Clinical signs or symptoms of congestive heart failure
• Severe valvular heart disease requiring either surgical or percutaneous intervention
• History of coronary artery bypass grafting
• Tortuous coronary anatomy in which wire manipulation could be complex
• Significant arrhythmia
• Use of vasoactive medications within 24 hours of coronary angiography

Sponsors & Collaborators

• VZW Cardiovascular Research Center Aalst: lead

Study Sites (1)

OLV Cardiovascular Center Aalst

Aalst, Flanders, 9300, Belgium

Location

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris; Coronary Artery Disease

Interventions

Nitroglycerin; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 12, 2025
• Study Start: July 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)