An observational study in Atheroma, Cardiac Disease and Vascular Diseases, sponsored by Dr. Amer Johri. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-09.
Sponsored by Dr. Amer Johri · Observational
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The investigators plan to evaluate the correlation between carotid plaque enhancement on Contrast-enhanced ultrasound (CEUS), significant coronary artery disease (CAD), and cardiovascular (CV) outcomes in a systematic manner. The investigators hypothesize that increased levels of CEUS-detected vulnerable carotid plaque will be predictive of CV risk determined by angiography and future cardiovascular events.
Study Design: The investigators will conduct a prospective, single-center, observational study at the Cardiovascular Imaging Network at Queen's (CINQ, www.CINQLab.com). This facility allows a CEUS protocol to be conducted on the same day as the angiogram. It is anticipated that 100 participants can be recruited per month with a total target enrolment of up to 1000 participants.
Objectives
105 studies on the registry are indexed under Plaque, Atherosclerotic; 27 are open to participants now.
This study's enrollment of 610 is above the median of 146 across 50 observational studies indexed under Plaque, Atherosclerotic.
Browse Plaque, Atherosclerotic studies →Dr. Amer Johri is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects referred for outpatient coronary angiography will be screened for inclusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects referred for outpatient coronary angiography.
Other: Ultrasound
Contrast-enhanced ultrasound (CEUS)
Also known as: Contrast injection - Definity(R)
Maximum Plaque Height (physiological parameter)
Caliper measurement of carotid plaque height on ultrasound images, using GE EchoPAC software. The maximum height of either side will be used to correlate to severity of angiographic CAD and neovascularization score.
Time frame: 4 years
Total Plaque Area (physiological parameter)
Area measurement of carotid plaque on ultrasound images (right + left side), using GE EchoPAC software. The total plaque area will be used to correlate to severity of angiographic CAD and neovascularization score.
Time frame: 4 years
Neovascularization (contrast enhancement intensity) (physiological parameter)
A neovascularization score will be used to grade the "activity" of the carotid plaque per participants and be correlated to angiographic CAD, visualized and manually counted using GE EchoPAC software.
Time frame: 4 years
Contrast wash-in time (physiological parameter)
Time of contrast entering the plaque will be assessed to see if it correlates to severity of angiographic CAD, using GE EchoPAC software.
Time frame: 4 years
Participants CV outcome follow-up (data linkage through the Institute for Clinical Evaluative Sciences: ICES)
Participants will be followed for major adverse cardiac event over 5 years. Number of events will be correlated to carotid plaque measurements.
Time frame: 5 years
Plan to share: No
Ran from Dec 2016 to primary completion in Jun 2021, 54 months.
Of 31 observational studies under Plaque, Atherosclerotic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 105. This study's 54 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Dr. Amer Johri