Cardiovascular DiseasesNCT06031077
Effectiveness and Safety of Distal Left Transradial Access in Coronary Procedures.
An observational study of Cardiovascular Diseases and Cardiomyopathies, run by The University of The West Indies at 1 site in Trinidad and Tobago.
Trial summary
To evaluate the effectiveness and safety of distal left radial (dLR) access in coronary procedures at a tertiary center in Trinidad and Tobago. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Cardiovascular Diseases, Cardiomyopathies
- What is being tested?
- cardiac catheterization
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteTrinidad and Tobago
- Study dates
- 1 Jan 2020to 30 Dec 2023
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Caribbean decent population of Trinidad and Tobago.
Cardiologist recommended guidelines.
Trial locations and contacts
1 site in 1 country.
Trinidad and Tobago1 site
Eric Williams Medical Sciences Complex
Port of Spain, North Central, 00000
About this study
To evaluate the effectiveness and safety of distal left radial (dLR) access in coronary procedures at a tertiary center in Trinidad and Tobago.
Read the detailed description
An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
- Conditions
- Cardiovascular Diseases, Cardiomyopathies
- Being tested
- cardiac catheterization
- Keywords
- Distal Radial Artery Angiogram, Anatomical Snuff Box Angiogram
- Medical subject headings
- Cardiovascular Diseases, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac catheterizationProcedure or surgery
An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
| Study group | Role | What they receive |
|---|---|---|
| Cardiologist Assessed Conditions. | The consultant Cardiologist will decide on the various types of presentations and symptoms that will be use full in generating this study. Receives: Procedure: cardiac catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of snuff box access to radial access for coronary angiography in Trinidad and Tobago.
An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
Measured: roughly 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Jan 2020
- Primary completion30 Aug 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naveen Seecheran, The University of The West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031077
- Sponsor's protocol ID
- CREC-SA.1304/12/2021
- Status last verified
- Jan 2024
- First submitted
- 20 Jul 2023
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The principal reason for this study is to aid physicians with the necessary data to perform cardiac catherisation and to show them different access points.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Distal Left Transradial Access in Coronary Procedures.
- ClinicalTrials.gov ID
- NCT06031077
- Acronym / sponsor ID
- CREC-SA.1304/12/2021
- Conditions
- Cardiovascular Diseases, Cardiomyopathies
- Keywords
- Distal Radial Artery Angiogram, Anatomical Snuff Box Angiogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 11 Sep 2023 (actual)
- 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.
To evaluate the effectiveness and safety of distal left radial (dLR) access in coronary procedures at a tertiary center in Trinidad and Tobago.
Detailed description
An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiologist Assessed Conditions. | – | Procedure: cardiac catheterizationThe consultant Cardiologist will decide on the various types of presentations and symptoms that will be use full in generating this study. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caribbean decent population of Trinidad and Tobago.
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 |
|---|---|---|
| cardiac catheterizationAn observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box. | Procedure or surgery | Cardiologist Assessed Conditions. |
Primary outcome
Comparison of snuff box access to radial access for coronary angiography in Trinidad and Tobago.
Time frame: roughly 3 years
An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.
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 22 Jan 2024.
- Individual participant dataSharing planned: No. The principal reason for this study is to aid physicians with the necessary data to perform cardiac catherisation and to show them different access points.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Cardiomyopathies, run by The University of The West Indies at 1 site in Trinidad and Tobago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Jan 2024. 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 Trinidad and Tobago. 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.
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?
Comparison of snuff box access to radial access for coronary angiography in Trinidad and Tobago. (time frame: roughly 3 years). 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 22 Jan 2024.