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

Primary Purpose

Ischemic Heart Diseases

Status
Completed
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Radial Technical
Femoral Technical
Omnipaque
Sponsored by
Centro Cardiológico del Caribe, Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Diseases

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Clinica General del Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radial Technical

Femoral Technical

Arm Description

Radial technical is the procedure for catheterization

Vascular Access for cardiac catheterization

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Minute of Fluoroscopic time
This secindary outcome is the time in minutes spent during fluoroscopy

Full Information

First Posted
October 25, 2013
Last Updated
November 14, 2013
Sponsor
Centro Cardiológico del Caribe, Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01984411
Brief Title
Comparison of Vascular Access for Radial and Femoral Completion of Diagnostic Cardiac Catheterization
Acronym
COMPACT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Cardiológico del Caribe, Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radial Technical
Arm Type
Experimental
Arm Description
Radial technical is the procedure for catheterization
Arm Title
Femoral Technical
Arm Type
Active Comparator
Arm Description
Vascular Access for cardiac catheterization
Intervention Type
Procedure
Intervention Name(s)
Radial Technical
Intervention Description
Vascular Access for cardiac catheterization
Intervention Type
Procedure
Intervention Name(s)
Femoral Technical
Intervention Description
Vascular Access for cardiac catheterization
Intervention Type
Drug
Intervention Name(s)
Omnipaque
Other Intervention Name(s)
Iohexol
Primary Outcome Measure Information:
Title
Minutes Total Procedure Time
Description
The primary outcome measure in this trial, is the time in minutes spent on the realization of the entire cardiac catheterization procedure
Time Frame
Assess the total duration of the procedure in minutes. Up to 15 min
Secondary Outcome Measure Information:
Title
Minute of Fluoroscopic time
Description
This secindary outcome is the time in minutes spent during fluoroscopy
Time Frame
Assess the total duration of the procedure in minutes. Up to 5 min
Other Pre-specified Outcome Measures:
Title
Complications
Description
Vascular and Clinical complications
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celin Malkun, MD, MSc
Organizational Affiliation
Centro Cardiológico del Caribe, Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge Luis Acosta, MD, MSc
Organizational Affiliation
Universidad del Norte, Barranquilla, Colombia
Official's Role
Study Director
Facility Information:
Facility Name
Clinica General del Norte
City
Barranquilla
State/Province
Atlco
ZIP/Postal Code
NT
Country
Colombia

12. IPD Sharing Statement

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

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