AtheromaVIBENCT03466255
Early Detection of Cardiovascular Disease
An observational study of Atheroma and Cardiac Disease, run by Dr. Amer Johri at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atheroma, Cardiac Disease, Vascular Diseases
- What is being tested?
- Ultrasound
- Type of treatment
- Injection or infusion
- How many people
- 610 participants
- Where
- 1 siteCanada
- Study dates
- 6 Dec 2016to 11 Jan 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects referred for outpatient coronary angiography will be screened for inclusion.
Who may be able to join
- >18 years of age
- Outpatients referred for clinically indicated angiography for assessment of CAD
- Low - Intermediate Framingham risk (<20%)
- Absence of clinical contraindication to angiography
- Able and willing to give informed consent
Who cannot join
- Patients presenting with acute coronary syndrome
- Patients with previously known significant CAD (any lesion >50%) or percutaneous coronary intervention or coronary artery bypass surgery
- Previous carotid surgery or angioplasty
- Documented allergy to echo contrast
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen's University, Cardiovascular Imaging Network at Queen's (CINQ), Kingston General Hospital
Kingston, Ontario, K7L 3N6
About this study
Official title: Vascular Imaging as a Barometer for the Early Detection of Cardiovascular Disease
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.
Read the detailed description
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
- To determine the test characteristics (sensitivity, specificity, negative/positive predictive values) of carotid plaque by CEUS (Definity(R)) for predicting significant CAD (≥50% stenosis) in participants referred for angiography
- To determine the test characteristics (sensitivity, specificity, predictive values) of carotid plaque by CEUS for predicting future CV events, such as death, stroke, myocardial infarction, and cardiovascular interventions.
- Conditions
- Atheroma, Cardiac Disease, Vascular Diseases, Atherosclerosis, Myocardial Infarction, Acute Coronary Syndrome
- Being tested
- Ultrasound
- Medical subject headings
- Plaque, Atherosclerotic, Heart Diseases, Vascular Diseases, Atherosclerosis, Myocardial Infarction, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Also called Contrast injection - Definity(R)
Contrast-enhanced ultrasound (CEUS)
| Study group | Role | What they receive |
|---|---|---|
| Cardiac outpatients | Subjects referred for outpatient coronary angiography. Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start6 Dec 2016
- Primary completion8 Jun 2021
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtheromaStudies 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
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Amer Johri
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Responsible party
- Sponsor-investigator, Dr. Amer Johri, Queen's University
- Investigators
- Amer M Johri, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03466255
- Sponsor's protocol ID
- DMED-1927-16
- Other IDs
- CG#17006, ER15-11-029
- Acronym
- VIBE
- Status last verified
- Jun 2022
- First submitted
- 27 Feb 2018
- Last updated
- 9 Jun 2022
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Imaging as a Barometer for the Early Detection of Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT03466255
- Acronym / sponsor ID
- VIBE / DMED-1927-16
- Conditions
- Atheroma, Cardiac Disease, Vascular Diseases, Atherosclerosis, Myocardial Infarction, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Dr. Amer JohriUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 8 Jun 2021 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 15 Mar 2018 (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.
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.
Detailed description
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
- To determine the test characteristics (sensitivity, specificity, negative/positive predictive values) of carotid plaque by CEUS (Definity(R)) for predicting significant CAD (≥50% stenosis) in participants referred for angiography
- To determine the test characteristics (sensitivity, specificity, predictive values) of carotid plaque by CEUS for predicting future CV events, such as death, stroke, myocardial infarction, and cardiovascular interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac outpatients | – | Other: UltrasoundSubjects referred for outpatient coronary angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred for outpatient coronary angiography will be screened for inclusion.
Key inclusion criteria (5 listed)
- >18 years of age
- Outpatients referred for clinically indicated angiography for assessment of CAD
- Low - Intermediate Framingham risk (<20%)
- Absence of clinical contraindication to angiography
- Able and willing to give informed consent
Key exclusion criteria (4 listed)
- Patients presenting with acute coronary syndrome
- Patients with previously known significant CAD (any lesion >50%) or percutaneous coronary intervention or coronary artery bypass surgery
- Previous carotid surgery or angioplasty
- Documented allergy to echo contrast
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 |
|---|---|---|
| UltrasoundAlso: Contrast injection - Definity(R)Contrast-enhanced ultrasound (CEUS) | Other | Cardiac outpatients |
Primary outcome
Maximum Plaque Height (physiological parameter)
Time frame: 4 years
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.
Total Plaque Area (physiological parameter)
Time frame: 4 years
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.
Neovascularization (contrast enhancement intensity) (physiological parameter)
Time frame: 4 years
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.
Contrast wash-in time (physiological parameter)
Time frame: 4 years
Time of contrast entering the plaque will be assessed to see if it correlates to severity of angiographic CAD, using GE EchoPAC software.
1 secondary outcome
Participants CV outcome follow-up (data linkage through the Institute for Clinical Evaluative Sciences: ICES)
Time frame: 5 years
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 9 Jun 2022.
- Cardiovascular Imaging Network at Queen'sLink provided by the sponsor.
- 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.
Amer M Johri, MD principal investigator
Queen's University
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 Atheroma and Cardiac Disease, run by Dr. Amer Johri at 1 site in Canada.
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 5 inclusion and 4 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 9 Jun 2022. 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 Canada. 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?
Maximum Plaque Height (physiological parameter) (time frame: 4 years). The study lists 4 primary outcomes in all. 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 9 Jun 2022.