Ischemic Heart DiseasesPhase 3COMPACTNCT01984411
Comparison of Vascular Access for Radial and Femoral Completion of Diagnostic Cardiac Catheterization
A Phase 3 study testing Radial Technical, Femoral Technical and Omnipaque in people with Ischemic Heart Diseases, run by Centro Cardiológico del Caribe, Columbia at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Heart Diseases
- What is being tested?
- Radial Technical, Femoral Technical and Omnipaque
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2013to Aug 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Radial Technical, Femoral Technical, Omnipaque
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial TechnicalProcedure or surgery
Vascular Access for cardiac catheterization
Femoral TechnicalProcedure or surgery
Vascular Access for cardiac catheterization
OmnipaqueDrug
Also called Iohexol
| Study group | Role | What they receive |
|---|---|---|
| Radial Technical | Experimental | Radial technical is the procedure for catheterization Receives: Procedure: Radial Technical; Drug: Omnipaque |
| Femoral Technical | Active comparator | Vascular Access for cardiac catheterization Receives: Procedure: Femoral Technical; Drug: Omnipaque |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assess the total duration of the procedure in minutes. Up to 15 min
Secondary outcomes (1)
Minute of Fluoroscopic time
This secindary outcome is the time in minutes spent during fluoroscopy
Measured: Assess the total duration of the procedure in minutes. Up to 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Cardiológico del Caribe, Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celin Malkun, Centro Cardiológico del Caribe, Columbia
- Investigators
- Celin Malkun, MD, MSc, Principal investigator, Centro Cardiológico del Caribe, ColumbiaJorge Luis Acosta, MD, MSc, Study director, Universidad del Norte, Barranquilla, Colombia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984411
- Sponsor's protocol ID
- CCCColumbia
- Acronym
- COMPACT
- Status last verified
- Nov 2013
- First submitted
- 25 Oct 2013
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01984411
- Acronym / sponsor ID
- COMPACT / CCCColumbia
- Conditions
- Ischemic Heart Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Centro Cardiológico del Caribe, ColumbiaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 14 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial Technical | Experimental | Procedure: Radial Technical, Drug: OmnipaqueRadial technical is the procedure for catheterization |
| Femoral Technical | Active comparator | Procedure: Femoral Technical, Drug: OmnipaqueVascular Access for cardiac catheterization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radial TechnicalVascular Access for cardiac catheterization | Procedure or surgery | Radial Technical |
| Femoral TechnicalVascular Access for cardiac catheterization | Procedure or surgery | Femoral Technical |
| OmnipaqueAlso: Iohexol | Drug | Femoral Technical, Radial Technical |
Primary outcome
Minutes Total Procedure Time
Time frame: Assess the total duration of the procedure in minutes. Up to 15 min
The primary outcome measure in this trial, is the time in minutes spent on the realization of the entire cardiac catheterization procedure
1 secondary outcome
Minute of Fluoroscopic time
Time frame: Assess the total duration of the procedure in minutes. Up to 5 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celin Malkun, MD, MSc principal investigator
Centro Cardiológico del Caribe, Columbia
Jorge Luis Acosta, MD, MSc study director
Universidad del Norte, Barranquilla, Colombia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radial Technical, Femoral Technical and Omnipaque in people with Ischemic Heart Diseases, run by Centro Cardiológico del Caribe, Columbia at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minutes Total Procedure Time (time frame: Assess the total duration of the procedure in minutes. Up to 15 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.