Subcutaneous Nitroglycerin to Facilitate Trans-radial Access.

• Status: Unknown status
• Trial end date: 2018-04-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Treatments: Nitroglycerin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.