Subcutaneous Nitroglycerin to Facilitate Trans-radial Access.

NCT03304496 | Suspended Phase 4 DMC

• 1 other identifier: PT-17-044
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief Summary

Femoral artery approach to perform coronary procedures is considered the standard technique for vascular access due to optimal catheter control, lower thromboembolic complications and immediate access due to the large diameter of the artery. Trans-radial approach has been shown to reduce major bleeding complications, vascular complications related to the site of puncture, including death from all causes, and to prevent post-procedure limb rest, greater comfort for patients, immediate ambulation, early discharge and reduction of costs. Previous studies have shown that intravenous, topical and intraarterial use of nitroglycerin produces vasodilation of the radial artery. Extravascular (subcutaneous) administration of nitroglycerin is extremely effective in restoring the radial pulse, and allows adequate cannulation.

Conditions

Coronary Artery Disease

Keywords

Nitroglycerin; Vasodilator Agents; Subcutaneous Injection; Radial Artery; Coronary Angiography; Cardiac Catheterization; Coronary Angioplasty; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Compound of crossover to femoral access and/or access site-related vascular complications.

  Crossover to femoral access: number of cases in which the procedure could not be completed via radial artery and access via femoral artery was changed. Access site-related vascular complications: hematoma requiring intervention as an additional compression bandage, radial perforation / dissection, hemorrhage requiring transfusion, compartment syndrome, arteriovenous fistula, pseudoaneurysm, or any complication requiring surgical intervention.

  Within 72 hours or at hospital discharge (whichever occurs first).

Secondary Outcomes (8)

• Number of attempts to cannulate the radial artery (punctures).

  Through study completion, an average of 1 year.

• Time until obtaining the radial access.

  Through study completion, an average of 1 year.

• Improvement in radial pulse strength.

  Through study completion, an average of 1 year.

• Loss of radial artery flow (radial artery occlusion) at 30 days.

  At 30 days.

• Pain in the cannulated extremity.

  Through study completion, an average of 1 year.

Study Arms (2)

Nitroglycerin

EXPERIMENTAL

The intervention group will receive a subcutaneous "cocktail" with 0,5 ml of 500 mcg of nitroglycerin + 1 ml of 2% simple lidocaine.

Drug: Nitroglycerin 100 MCG/ML Injectable Solution

Control

PLACEBO COMPARATOR

The placebo group will receive a subcutaneous injection with 0,5 ml of 0,9% saline solution + 1 ml of 2% simple lidocaine.

Drug: Saline Solution

Interventions

Saline Solution DRUG

Previously described.

Control

Nitroglycerin 100 MCG/ML Injectable Solution DRUG

Previously described.

Nitroglycerin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women older than 18 years, scheduled consecutively to perform a coronary procedure in the department of hemodynamics of the National Institute of Cardiology "Ignacio Chavez".
• Patients may have any of the following indications for cardiac catheterization: Thoracic pain under study. Stable chronic coronary disease. Acute myocardial infarction with ST segment elevation, not perfused (without timely reperfusion therapy) with less than 4 weeks of evolution. Acute myocardial infarction with ST-segment elevation, successful thrombolytic therapy, which will undergo drug-invasive therapy. Acute myocardial infarction without ST segment elevation. Unstable angina. Any acute coronary syndrome, to intervene non-infarct-related artery. Disease of any heart valve. Myocarditis or pericarditis. Dilated cardiomyopathy. Patients in renal or cardiac transplantation protocol for any etiology. Congenital heart disease that requires knowing the coronary anatomy prior to surgical correction.
• The planned procedure can be any of the following: For diagnostic purposes (coronary angiography only, left catheterization, left and right catheterization). For therapeutic purposes: percutaneous coronary intervention (PCI), with or without stent placement.
• A priori access must be right or left radial artery.
• Radial arterial pulse may be present or absent by palpation.
• Modified Allen or Barbeau test should be positive (presence of collateral palmar flow).

You may not qualify if:

• Pregnant.
• Not have informed consent for the present clinical trial, or do not fully understand the meaning of informed consent.
• With acute myocardial infarction with ST segment elevation in the first 12 hours from the onset of symptoms.
• With any acute coronary syndrome complicated with acute pulmonary edema, cardiogenic shock and / or malignant ventricular arrhythmias.
• In which a cardiac catheterization is planned a priori to be performed via femoral, brachial or ulnar.
• Patients in whom first attempt of arterial puncture is performed by 2nd year interventional cardiology fellow or by physician in charge.
• Participating in another clinical trial.
• Be allergic or have contraindications to nitroglycerin or other nitrates.
• Any phosphodiesterase 5 inhibitor (sildenafil, tadalafil, avanafil, vardenafil) has been taken within 72 hours prior to the study.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, Tlalpan, 04480, Mexico

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Nitroglycerin; Saline Solution

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Marco Antonio Peña Duque, MD

  Director of Department of Interventional Cardiology, National Institute of Cardiology, Mexico City, Mexico.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2017
• First Posted: October 9, 2017
• Study Start: March 30, 2018
• Primary Completion: March 30, 2019
• Study Completion: March 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

ME (1)