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

NCT01984411 | Completed Phase 3

• 1 other identifier: CCCColumbia
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Heart Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Minute of Fluoroscopic time

  Assess the total duration of the procedure in minutes. Up to 5 min

Other Outcomes (1)

• Complications

  8 days

Study Arms (2)

Radial Technical

EXPERIMENTAL

Radial technical is the procedure for catheterization

Procedure: Radial Technical; Drug: Omnipaque

Femoral Technical

ACTIVE COMPARATOR

Vascular Access for cardiac catheterization

Procedure: Femoral Technical; Drug: Omnipaque

Interventions

Radial Technical PROCEDURE

Vascular Access for cardiac catheterization

Radial Technical

Femoral Technical PROCEDURE

Vascular Access for cardiac catheterization

Femoral Technical

Omnipaque DRUG

Also known as: Iohexol

Femoral Technical; Radial Technical

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Cardiológico del Caribe, Columbia: lead

Study Sites (1)

Clinica General del Norte

Barranquilla, Atlco, NT, Colombia

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Celin Malkun, MD, MSc

  Centro Cardiológico del Caribe, Columbia

  PRINCIPAL INVESTIGATOR

• Jorge Luis Acosta, MD, MSc

  Universidad del Norte, Barranquilla, Colombia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist Interventional

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: November 14, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

CO (1)