AtherosclerosisCIRCENCT05416385
Carotid Intraplaque Neovascularization Combined With Stress Echo
An observational study of Atherosclerosis and Cardiovascular Diseases, run by Dr. Amer Johri at 6 sites in Canada.
Trial summary
The root cause of heart attacks and strokes is atherosclerosis, the hardening and thickening of blood vessels due to the presence of "plaque" which is a build-up of fat and cholesterol in the walls of vessels. To diagnose heart disease, patients receive a stress test to find out if they require surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Cardiovascular Diseases, Acute Coronary Syndrome
- What is being tested?
- Carotid Contrast Enhanced Ultrasound
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- 6 sitesCanada
- Study dates
- 16 Aug 2021to 16 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Low to intermediate risk outpatient subjects referred for stress echo (SE) for assessment of ischemia and risk stratification will be screened for inclusion.
Who may be able to join
- Men and women >18 years;
- Referred for a clinically indicated SE for assessment of ischemia and risk stratification;
- Able and willing to give informed consent.
Who cannot join
- Emergency procedure, or active acute coronary syndrome (active chest pain, ischemic electrocardiogram changes, or cardiac enzyme elevation);
- Referral for viability, pulmonary hypertension, or valve assessment;
- Referral outside of the normal working hours;
- History of significant CAD: percutaneous coronary intervention (PCI), coronary artery bypass graft (GABG), or coronary angioplasty;
- History of stroke or myocardial infarction (MI);
- Known or documented hypersensitivity or allergy to perflutren (DEFINITY® contrast agent);
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- Known or documented allergy to Polyethylene Glycol (Peg) a component of DEFINITY®;
- History of carotid surgery (endarterectomy or stenting);
- Any serious medical condition or complication from the stress test that according to the investigator could interfere with the carotid scan or optimal care;
- Currently pregnant or breastfeeding;
- Previous enrolment into the study.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
University of Calgary
Calgary, Alberta, T2N 1N4
Omid Kiamanesh, MD
Nowell Fine, MD SM FRCPC
- Not yet recruiting
University of Alberta
Edmonton, Alberta, T6G 2R3
Eila Mirhadi, (780) 407-7682, eila.mirhadi@albertahealthservices.ca
Harald Becher, MD, PhD FRCP
- Recruiting
Dalhousie University
Halifax, Nova Scotia, B3H 3A7
Sharon Mulvagh, MD, FRCPC
- Recruiting
The Kingston Heart Clinic
Kingston, Ontario, K7L 1C2
Murray Matangi, MB ChB, FRCPC, FACP, FACC, (613) 544-3242;, cinq.research@gmail.com
Murray Matangi, MB ChB, FRCPC, FACP, FACC
- Recruiting
Queen's University, Cardiovascular Imaging Network at Queen's (CINQ)
Kingston, Ontario, K7L 2V7
Amer Johri, MD, amerschedule@gmail.com
- Recruiting
Unity Health Toronto
Toronto, Ontario, M5B 1W8
Howard Leong-Poi, MD, 416-864-5642, howard.Leong-Poi@unityhealth.to
Howard Leong-Poi, MD
About this study
Official title: Combining Intraplaque Neovascularization With Risk Stratification by Carotid Stress ECHO
The root cause of heart attacks and strokes is atherosclerosis, the hardening and thickening of blood vessels due to the presence of "plaque" which is a build-up of fat and cholesterol in the walls of vessels. To diagnose heart disease, patients receive a stress test to find out if they require surgery. Up to 52% of patients receiving an angiogram (surgery) to look at plaque blockages in the heart are found to be normal (no blockage). Patients who are suspected of having heart disease often undergo a stress test, which helps cardiologists decide if the patient has heart disease, but stress tests can give false results. In Ontario alone, 90% are stress tests are found to be normal and patients are sent home with little follow-up. Of these 3-5% (~4,000 patients/year) will have a major cardiovascular event (heart attack, surgery, or death) within 3 years. We need to improve the stress test accuracy to reduce cardiac outcome. We now know that it is not just the total amount of plaque that leads to heart attacks and strokes, but the composition of the plaque that can lead to breakage causing a heart attack. Plaques are soft and fragile, and typically contain fat and small leaky blood vessels within their cores. If we are able to identify patients that have leaky plaques using ultrasound, we may be able to improve the accuracy of stress testing. We propose a study looking at the combination of stress testing (assessing heart function) and neck ultrasound (assessing plaque composition), to identify patients at risk for cardiovascular events (heart attacks and death). We will enrol patients from 6 sites across Canada and follow-them for cardiac outcome for 3 years.
Read the detailed description
Primary Aim: To determine if carotid intraplaque neovascularization score (IPN) combined with stress echo (SE) [IPN+SE] enhances prediction of 3-year major adverse cardiovascular events (MACE) compared to SE alone.
Objectives: 1) The % change in test sensitivity of IPN+SE for predicting 3-year MACE compared with SE alone. 2) The Net Reclassification Improvement (NRI) for MACE will be determined (patients "missed" by the SE, but captured as high risk for MACE by IPN).
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Acute Coronary Syndrome, Ischemic Heart Disease, Myocardial Infarction, Carotid Artery Diseases
- Being tested
- Carotid Contrast Enhanced Ultrasound
- Keywords
- Ultrasound, Echocardiography, Stress Testing, Contrast Enhanced Ultrasound
- Medical subject headings
- Atherosclerosis, Cardiovascular Diseases, Acute Coronary Syndrome, Myocardial Ischemia, Myocardial Infarction, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Contrast Enhanced UltrasoundOther
Also called Contrast injection, DEFINITY®, Perflutren Lipid Microsphere
Carotid Contrast-Enhanced Ultrasound (CEUS), a diagnostic ultrasound enhancing agent that opacifies the blood to delineate the vessel walls.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac outpatients | Subjects referred for outpatient stress echocardiogram (SE). Receives: Other: Carotid Contrast Enhanced Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our primary outcomes will be the improvement in sensitivity and negative predictive value (NPV).
Our primary analysis will compare the sensitivity of an established binary test based on SE alone to a binary test based on SE and plaque assessment (using established thresholds, IPN≥1.25) to predict 3-year MACE.
Measured: This is a 5-year study. The outcome follow up for mace will be 3-years from the index date (SE).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start16 Aug 2021
- Primary completion16 Aug 2026 (estimated)
- Study completion16 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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
- 1,500 participants (estimated)
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 Johri, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416385
- Sponsor's protocol ID
- DMED-2469-21-6032717
- Other IDs
- CG#21007, 452696
- Acronym
- CIRCE
- Status last verified
- Feb 2025
- First submitted
- 8 Jun 2022
- Last updated
- 6 Feb 2025
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Intraplaque Neovascularization With Risk Stratification by Carotid Stress ECHO
- ClinicalTrials.gov ID
- NCT05416385
- Acronym / sponsor ID
- CIRCE / DMED-2469-21-6032717
- Conditions
- Atherosclerosis, Cardiovascular Diseases, Acute Coronary Syndrome, Ischemic Heart Disease, Myocardial Infarction, Carotid Artery Diseases
- Keywords
- Ultrasound, Echocardiography, Stress Testing, Contrast Enhanced Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Dr. Amer JohriUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 16 Aug 2026 (estimated)
- Study completion
- 16 Aug 2026 (estimated)
- First posted
- 13 Jun 2022 (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 root cause of heart attacks and strokes is atherosclerosis, the hardening and thickening of blood vessels due to the presence of "plaque" which is a build-up of fat and cholesterol in the walls of vessels. To diagnose heart disease, patients receive a stress test to find out if they require surgery. Up to 52% of patients receiving an angiogram (surgery) to look at plaque blockages in the heart are found to be normal (no blockage). Patients who are suspected of having heart disease often undergo a stress test, which helps cardiologists decide if the patient has heart disease, but stress tests can give false results. In Ontario alone, 90% are stress tests are found to be normal and patients are sent home with little follow-up. Of these 3-5% (~4,000 patients/year) will have a major cardiovascular event (heart attack, surgery, or death) within 3 years. We need to improve the stress test accuracy to reduce cardiac outcome. We now know that it is not just the total amount of plaque that leads to heart attacks and strokes, but the composition of the plaque that can lead to breakage causing a heart attack. Plaques are soft and fragile, and typically contain fat and small leaky blood vessels within their cores. If we are able to identify patients that have leaky plaques using ultrasound, we may be able to improve the accuracy of stress testing. We propose a study looking at the combination of stress testing (assessing heart function) and neck ultrasound (assessing plaque composition), to identify patients at risk for cardiovascular events (heart attacks and death). We will enrol patients from 6 sites across Canada and follow-them for cardiac outcome for 3 years.
Detailed description
Primary Aim: To determine if carotid intraplaque neovascularization score (IPN) combined with stress echo (SE) [IPN+SE] enhances prediction of 3-year major adverse cardiovascular events (MACE) compared to SE alone.
Objectives: 1) The % change in test sensitivity of IPN+SE for predicting 3-year MACE compared with SE alone. 2) The Net Reclassification Improvement (NRI) for MACE will be determined (patients "missed" by the SE, but captured as high risk for MACE by IPN).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac outpatients | – | Other: Carotid Contrast Enhanced UltrasoundSubjects referred for outpatient stress echocardiogram (SE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Low to intermediate risk outpatient subjects referred for stress echo (SE) for assessment of ischemia and risk stratification will be screened for inclusion.
Key inclusion criteria (3 listed)
- Men and women >18 years;
- Referred for a clinically indicated SE for assessment of ischemia and risk stratification;
- Able and willing to give informed consent.
Key exclusion criteria (11 listed)
- Emergency procedure, or active acute coronary syndrome (active chest pain, ischemic electrocardiogram changes, or cardiac enzyme elevation);
- Referral for viability, pulmonary hypertension, or valve assessment;
- Referral outside of the normal working hours;
- History of significant CAD: percutaneous coronary intervention (PCI), coronary artery bypass graft (GABG), or coronary angioplasty;
- History of stroke or myocardial infarction (MI);
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 |
|---|---|---|
| Carotid Contrast Enhanced UltrasoundAlso: Contrast injection, DEFINITY®, Perflutren Lipid MicrosphereCarotid Contrast-Enhanced Ultrasound (CEUS), a diagnostic ultrasound enhancing agent that opacifies the blood to delineate the vessel walls. | Other | Cardiac outpatients |
Primary outcome
Our primary outcomes will be the improvement in sensitivity and negative predictive value (NPV).
Time frame: This is a 5-year study. The outcome follow up for mace will be 3-years from the index date (SE).
Our primary analysis will compare the sensitivity of an established binary test based on SE alone to a binary test based on SE and plaque assessment (using established thresholds, IPN≥1.25) to predict 3-year MACE.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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.
Amer Johri, MD principal investigator
Queen's University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Cardiovascular Diseases, run by Dr. Amer Johri at 6 sites 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-France Hetu, PhD (1 613-549-6666 ext. 8174, cinq.research@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our primary outcomes will be the improvement in sensitivity and negative predictive value (NPV). (time frame: This is a 5-year study. The outcome follow up for mace will be 3-years from the index date (SE).). 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 6 Feb 2025.