Intravascular Ultrasound (IVUS) Angiography Co-registrationNCT02373826
Novel Method for Real Time Co-Registration of IVUS and Coronary Angiography
An observational study of Intravascular Ultrasound (IVUS) Angiography Co-registration, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion length and luminal reference diameter. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intravascular Ultrasound (IVUS) Angiography Co-registration
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Mar 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing routine coronary angioplasty
Who may be able to join
- Patients undergoing routine coronary angioplasty
Who cannot join
- Cardiogenic shock
- Acute myocardial infarction
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 38100
Aharon Frimerman, MD, 972-52-3543264, afrimer@gmail.com
About this study
During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion length and luminal reference diameter. We aimed to investigate the accuracy, feasibility, safety and value of a novel method for co-registration of IVUS and coronary angiographic images.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Co-Registration of IVUS and Coronary Angiography
For determination of the accuracy of the co-registration feature, and the accuracy and precision of the length measurements, a flexible phantom was used in order to simulate an artery and enable simulation of the cardiac motion. The sample size for testing the co-registration algorithm was 108 samples (each sample was defined as a landmark). The resultant mean of the absolute distance accuracy was 0.995 mm with a standard deviation of 0.809 mm. The statistical validation in phantoms, resulted in an accuracy of 1.12 mm, meeting the original specification.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravascular Ultrasound (IVUS) Angiography Co-registrationStudies 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
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373826
- Sponsor's protocol ID
- 0028-13-HYMC
- Status last verified
- Mar 2015
- First submitted
- 16 Feb 2015
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Method for Real Time Co-Registration of IVUS and Coronary Angiography
- ClinicalTrials.gov ID
- NCT02373826
- Acronym / sponsor ID
- 0028-13-HYMC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2015
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 27 Feb 2015 (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.
During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion length and luminal reference diameter. We aimed to investigate the accuracy, feasibility, safety and value of a novel method for co-registration of IVUS and coronary angiographic images.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing routine coronary angioplasty
Key inclusion criteria (1 listed)
- Patients undergoing routine coronary angioplasty
Key exclusion criteria (2 listed)
- Cardiogenic shock
- Acute myocardial infarction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of Co-Registration of IVUS and Coronary Angiography
Time frame: One month
For determination of the accuracy of the co-registration feature, and the accuracy and precision of the length measurements, a flexible phantom was used in order to simulate an artery and enable simulation of the cardiac motion. The sample size for testing the co-registration algorithm was 108 samples (each sample was defined as a landmark). The resultant mean of the absolute distance accuracy was 0.995 mm with a standard deviation of 0.809 mm. The statistical validation in phantoms, resulted in an accuracy of 1.12 mm, meeting the original specification.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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.
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 Intravascular Ultrasound (IVUS) Angiography Co-registration, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Mar 2015. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aharon Frimerman, MD (972-52-3543264, afrimer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Co-Registration of IVUS and Coronary Angiography (time frame: One 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 10 Mar 2015.