Myocardial Bridge of Coronary ArteryNCT04869150
Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography
An observational study of Myocardial Bridge of Coronary Artery, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Although the incidence of myocardial bridge (MB) has been defined in different conventional coronary angiography (CCA) studies,the frequency of MB in radial access coronary angiography (RACA) is unknown.The aim of this study was to determine the incidence of MB in patients undergoing RACA. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Myocardial Bridge of Coronary Artery
- What is being tested?
- radial access coronary angiography
- Type of treatment
- Surgery or procedure
- How many people
- 255 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Feb 2018to 29 Mar 2021
- How long will I take part?
- 2 Years
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A retrospective evaluation was made of the coronary angiographies of 2600 consecutive patients who underwent radial access coronary angiography between January 2018 and February 2020
Who may be able to join
- Undergoing radial access coronary angiography
- Have myocardial bridge
Who cannot join
- A history of coronary artery bypass grafting (CABG)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cigli Training and Research Hospital Organization
Although the incidence of myocardial bridge (MB) has been defined in different conventional coronary angiography (CCA) studies,the frequency of MB in radial access coronary angiography (RACA) is unknown.The aim of this study was to determine the incidence of MB in patients undergoing RACA.
- Conditions
- Myocardial Bridge of Coronary Artery
- Being tested
- radial access coronary angiography
- Keywords
- myocardial bridge, radial access coronary angiography
- Medical subject headings
- Myocardial Bridging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial access coronary angiographyProcedure or surgery
The right radial artery was cannulated with a 6-f radial sheath after local infiltration with 2% lidocaine.All patients received 5000 units of unfractionated heparin, 100 - 200 μg (depending on blood pressure) of nitroglycerin and 5 mg of diltiazem unless there was an absolute contraindication to diltiazem and anticoagulants.Coronary angiography was performed using the standard Judkins' technique via right radial access with a 5-f diagnostic catheter
| Study group | Role | What they receive |
|---|---|---|
| those with myocardial bridges | Not described Receives: Procedure: radial access coronary angiography | |
| those without myocardial bridges | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography?
the incidence of MB able to be detected on RACA was much higher than reported in previous CCA studies.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start8 Feb 2018
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Bridge of Coronary ArteryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oktay Senoz, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869150
- Sponsor's protocol ID
- 223-205
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cigli Training and Research Hospital Organization
- ClinicalTrials.gov ID
- NCT04869150
- Acronym / sponsor ID
- 223-205
- Conditions
- Myocardial Bridge of Coronary Artery
- Keywords
- myocardial bridge, radial access coronary angiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 3 May 2021 (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.
Although the incidence of myocardial bridge (MB) has been defined in different conventional coronary angiography (CCA) studies,the frequency of MB in radial access coronary angiography (RACA) is unknown.The aim of this study was to determine the incidence of MB in patients undergoing RACA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| those with myocardial bridges | – | Procedure: radial access coronary angiography |
| those without myocardial bridges | – | – |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A retrospective evaluation was made of the coronary angiographies of 2600 consecutive patients who underwent radial access coronary angiography between January 2018 and February 2020
Key inclusion criteria (2 listed)
- Undergoing radial access coronary angiography
- Have myocardial bridge
Key exclusion criteria (1 listed)
- A history of coronary artery bypass grafting (CABG)
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 access coronary angiographyThe right radial artery was cannulated with a 6-f radial sheath after local infiltration with 2% lidocaine.All patients received 5000 units of unfractionated heparin, 100 - 200 μg (depending on blood pressure) of nitroglycerin and 5 mg of diltiazem unless there was an absolute contraindication to diltiazem and anticoagulants.Coronary angiography was performed using the standard Judkins' technique via right radial access with a 5-f diagnostic catheter | Procedure or surgery | those with myocardial bridges |
Primary outcome
Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography?
Time frame: 1 month
the incidence of MB able to be detected on RACA was much higher than reported in previous CCA studies.
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 5 May 2021.
- Individual participant dataSharing planned: No
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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 Myocardial Bridge of Coronary Artery, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
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 2 inclusion and 1 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 5 May 2021. 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 Turkey (Türkiye). 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?
Does Myocardial Bridge Appear More Frequently and Diffusely on Radial Access Coronary Angiography? (time frame: 1 month). 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 5 May 2021.