Coronary Artery VesselsNCT02741661
Influence of Myocardial Shortening on Coronary Tortuosity
An observational study of Coronary Artery Vessels and Coronary Artery Disease, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This study is a retrospective analysis where coronary arteriograms are being analyzed to determine whether the presence of tortuous coronary arteries correlate with any specific measures of left ventricular mass or left ventricular function on echocardiography. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Coronary Artery Vessels, Coronary Artery Disease
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2016
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective study of subjects who have undergone clinically-indicated coronary arteriography who also have an echocardiogram that was performed within 3 months of the angiogram.
Who may be able to join
- subjects referred for angiography
- echocardiography performed within 3 months.
Who cannot join
- connective tissue disease
- severe LV dysfunction
- prior coronary artery bypass surgery
- major adverse coronary event between angiogram and echo procedures
- moderate or greater valve disease
- acute coronary syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Coronary Tortuosity
This study is a retrospective analysis where coronary arteriograms are being analyzed to determine whether the presence of tortuous coronary arteries correlate with any specific measures of left ventricular mass or left ventricular function on echocardiography.
- Conditions
- Coronary Artery Vessels, Coronary Artery Disease
- Being tested
- No intervention. Observational study
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention. Observational studyOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Normal coronary arteries | Patients in whom coronary arteriography has demonstrated no significant tortuosity. Receives: Other: No intervention. Observational study | |
| Tortuous coronary arteries | Patients in whom coronary arteriography has demonstrated tortuous coronary arteries defined as >1 major bend of >45 degrees in a major coronary artery Receives: Other: No intervention. Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of longitudinal shortening
Measurement of longitudinal shortening of the left ventricle measured on an echocardiography (retrospectively) that was performed within 3 months of the angiogram
Measured: 3 months
Secondary outcomes (1)
LV mass
Measurement of longitudinal shortening of the left ventricle measured on an echocardiography (retrospectively) that was performed within 3 months of the angiogram
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJul 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery VesselsStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan R. Lindner, MD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741661
- Sponsor's protocol ID
- Coronary Tortuosity
- Status last verified
- Sep 2016
- First submitted
- 13 Apr 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Coronary Tortuosity
- ClinicalTrials.gov ID
- NCT02741661
- Acronym / sponsor ID
- Coronary Tortuosity
- Conditions
- Coronary Artery Vessels, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 18 Apr 2016 (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.
This study is a retrospective analysis where coronary arteriograms are being analyzed to determine whether the presence of tortuous coronary arteries correlate with any specific measures of left ventricular mass or left ventricular function on echocardiography.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal coronary arteries | – | Other: No intervention. Observational studyPatients in whom coronary arteriography has demonstrated no significant tortuosity. |
| Tortuous coronary arteries | – | Other: No intervention. Observational studyPatients in whom coronary arteriography has demonstrated tortuous coronary arteries defined as >1 major bend of >45 degrees in a major coronary artery |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective study of subjects who have undergone clinically-indicated coronary arteriography who also have an echocardiogram that was performed within 3 months of the angiogram.
Key inclusion criteria (2 listed)
- subjects referred for angiography
- echocardiography performed within 3 months.
Key exclusion criteria (6 listed)
- connective tissue disease
- severe LV dysfunction
- prior coronary artery bypass surgery
- major adverse coronary event between angiogram and echo procedures
- moderate or greater valve disease
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 |
|---|---|---|
| No intervention. Observational studyNo intervention | Other | Normal coronary arteries, Tortuous coronary arteries |
Primary outcome
Degree of longitudinal shortening
Time frame: 3 months
Measurement of longitudinal shortening of the left ventricle measured on an echocardiography (retrospectively) that was performed within 3 months of the angiogram
1 secondary outcome
LV mass
Time frame: 3 months
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 27 Sep 2016.
- Individual participant dataSharing planned: Yes
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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 Coronary Artery Vessels and Coronary Artery Disease, run by Oregon Health and Science University at 1 site in United States.
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 6 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 27 Sep 2016. 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 United States. 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?
Degree of longitudinal shortening (time frame: 3 months). 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 27 Sep 2016.