Status:
UNKNOWN
Subcutaneous Nitroglycerin to Facilitate Trans-radial Access.
Lead Sponsor:
Instituto Nacional de Cardiologia Ignacio Chavez
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Detailed Description
Unlike femoral access, the trans-radial approach to coronary angiography requires a greater learning curve for the inexperienced interventionist, and demands a greater technical challenge than the fem...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2018
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT03304496
Start Date
March 30 2017
End Date
April 15 2018
Last Update
October 9 2017
Active Locations (1)
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1
Instituto Nacional de Cardiologia Ignacio Chavez
Mexico City, Tlalpan, Mexico, 04480