Comparison of Vascular Access for Radial and Femoral Completion of Diagnostic Cardiac Catheterization (COMPACT)

Comparison of Vascular ACcess for Radial and Femoral Completion of Diagnostic Cardiac Catheterization Performed at the Clinic Patients Northern General de Barranquilla in 2013. Controlled Clinical Trial of Non-inferiority

Cardiac catheterization is the most important test for the evaluation of cardiac patients. Since the beginning of the cardiac catheterization procedure, we have used the femoral artery puncture as a gateway for those procedures. Recently it is used more often the path for the radial. Using this approach has gained many followers worldwide and has been used almost routinely in our country but has not gained popularity because many interventional cardiologists argue that the transradial procedure is much more time-consuming and difficult.

Research question: Are there differences in the total procedure time path between radial and femoral vascular to perform cardiac catheterizations?.

This research focuses on the search for information to determine whether there are significant differences when the variables under study. This research is justified by the need to evaluate the two techniques in use and the lack of studies evaluating and comparing the radial arterial access in comparison with femoral access route which is widely used in all services hemodynamics national and international. The lack of research on the subject has made the use of the transradial procedure routinely not being done, because they have the idea that it is much more time-consuming and technically more difficult than the procedure performed by the femoral approach, hence Hemodynamics specialists, not everyone wants to start implementing the systematic use of the radial approach for cardiac catheterization studies.The main objective of this project is to determine the non-inferiority in terms of total procedure time path between radial and femoral vascular to perform cardiac catheterizations. Secondary objectives: the difference in time of puncture, duration of the procedure and recovery. Incidence of vascular complications and techniques between radial and femoral, presence of complications at 8 days of follow-up. Our aims to check through the results, if the difference in each of the variables favoring either of the two techniques and to determine the non-inferiority of one technique over the other in terms of ease and effectiveness of both procedures. The type of study is a controlled clinical trial open, randomized, non-inferiority. The study population will consist of patients who have been told the diagnostic cardiac catheterization, they are sent to the General Clinic Northern institution.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Diseases
• Intervention / Treatment: Procedure: Radial Technical; Drug: Omnipaque; Procedure: Femoral Technical

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Atlco
    • Barranquilla, Atlco, Colombia, NT
      • Clínica General del Norte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients over 18 years
• Patients requiring a performing diagnostic cardiac catheterization procedure, scheduled electively or urgently,
• Patients mentally healthy
• Patients with test Allen (palmar arch patency) normal
• Patients who signing the informed consent.

Exclusion Criteria:

• Patients with a history of allergic reaction to the dye.
• Patients with peripheral vascular disease.
• Anticoagulated patients with coumarinic or other oral anticoagulants.
• Patients with arteriovenous fistula for hemodialysis.
• Patients with a history of coronary artery bypass surgery.
• Patients with amputations or upper limb deformities.
• Patients with limited movement in the upper limbs or burns contractures.
• Patients requiring catheterization while the right heart do.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radial Technical; Radial technical is the procedure for catheterization	Procedure: Radial Technical; Vascular Access for cardiac catheterization; Drug: Omnipaque; Other Names: Iohexol
Active Comparator: Femoral Technical; Vascular Access for cardiac catheterization	Drug: Omnipaque; Other Names: Iohexol; Procedure: Femoral Technical; Vascular Access for cardiac catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minutes Total Procedure Time	The primary outcome measure in this trial, is the time in minutes spent on the realization of the entire cardiac catheterization procedure	Assess the total duration of the procedure in minutes. Up to 15 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minute of Fluoroscopic time	This secindary outcome is the time in minutes spent during fluoroscopy	Assess the total duration of the procedure in minutes. Up to 5 min

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Vascular and Clinical complications	8 days

Collaborators and Investigators

• Sponsor: Centro Cardiológico del Caribe, Columbia
• Investigators: Principal Investigator: Celin Malkun, MD, MSc, Centro Cardiológico del Caribe, Columbia; Study Director: Jorge Luis Acosta, MD, MSc, Universidad del Norte, Barranquilla, Colombia

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Estimate): November 15, 2013
• Last Update Submitted That Met QC Criteria: November 14, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: CCCColumbia