Cardiovascular Risk StratificationNCT02245048
CIMT and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification
An observational study of Cardiovascular Risk Stratification and Carotid Intima-media Thickness (CIMT), run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to determine if carotid artery ultrasound scanning can provide additional information for determining cardiovascular risk in patients. Patients who agree to participate wil undergo non-invasive carotid intima-media thickness (CIMT) measurement and plaque assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Risk Stratification, Carotid Intima-media Thickness (CIMT), Stress Echocardiography (SE)
- What is being tested?
- Carotid Intima-Media Thickness (CIMT)
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be undergoing standard of care stress echocardiography
Who may be able to join
- Asymptomatic
- No prior cardiac history (MI, PTCA, CABG, angina)
- No peripheral vascular disease
- No history of stroke or TIA
- Statins, antihypertensives, ASA treatment OK
Who cannot join
- History of CAD, CABG, PTCA, coronary or peripheral stenting
- History of stroke/TIA/peripheral vascular disease
- Inability to exercise on the treadmill
- Unwilling/unable to sign informed consent
- History of neck radiation or neck surgery or inability to obtain neck images
- End stage renal disease
- Preoperative evaluation
- History of chest pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carotid Intima-Media Thickness and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification
The purpose of this research study is to determine if carotid artery ultrasound scanning can provide additional information for determining cardiovascular risk in patients.
Patients who agree to participate wil undergo non-invasive carotid intima-media thickness (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of patient standard of care stress echocardiogram (SE) and of diastolic function.
We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications, CIMT and plaque assessment will provide useful risk stratification beyond use of traditional risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise capacity and 3) Exercise capacity will correlate with diastolic function.
- Conditions
- Cardiovascular Risk Stratification, Carotid Intima-media Thickness (CIMT), Stress Echocardiography (SE)
- Being tested
- Carotid Intima-Media Thickness (CIMT)
- Keywords
- Cardiovascular Risk Stratification, Carotid intima-media thickness (CIMT), Stress echocardiography (SE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid Intima-Media Thickness (CIMT)Other
| Study group | Role | What they receive |
|---|---|---|
| Stress Echocardiography (SE) | Subjects will undergo CIMT measurements. Receives: Other: Carotid Intima-Media Thickness (CIMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram
We are comparing the % of patients with abnormal IMT defined as presence of plaque (= or >1.5mm) or CIMT >75% percentile for age, race, and gender compared to % of patients with positive ischemia on stress echocardiogram as defined by a new wall motion abnormality on echocardiogram with stress.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk StratificationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Esaote North America
- Responsible party
- Principal investigator, Tasneem Z. Naqvi, M.D., Mayo Clinic
- Investigators
- Tasneem Naqvi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245048
- Sponsor's protocol ID
- 13-008535
- Status last verified
- May 2023
- First submitted
- 17 Sep 2014
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Intima-Media Thickness and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk Stratification
- ClinicalTrials.gov ID
- NCT02245048
- Acronym / sponsor ID
- 13-008535
- Conditions
- Cardiovascular Risk Stratification, Carotid Intima-media Thickness (CIMT), Stress Echocardiography (SE)
- Keywords
- Cardiovascular Risk Stratification, Carotid intima-media thickness (CIMT), Stress echocardiography (SE)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Esaote North America
- Study start
- Oct 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Sep 2014 (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.
The purpose of this research study is to determine if carotid artery ultrasound scanning can provide additional information for determining cardiovascular risk in patients.
Patients who agree to participate wil undergo non-invasive carotid intima-media thickness (CIMT) measurement and plaque assessment. Findings of CIMT will be compared to results of patient standard of care stress echocardiogram (SE) and of diastolic function.
We hypothesize tht 1) in patients undergoing SE for inappropriate or uncertain indications, CIMT and plaque assessment will provide useful risk stratification beyond use of traditional risk factors; 2) CIMT findings will correlate with results of SE in terms of exercise capacity and 3) Exercise capacity will correlate with diastolic function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stress Echocardiography (SE) | – | Other: Carotid Intima-Media Thickness (CIMT)Subjects will undergo CIMT measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be undergoing standard of care stress echocardiography
Key inclusion criteria (5 listed)
- Asymptomatic
- No prior cardiac history (MI, PTCA, CABG, angina)
- No peripheral vascular disease
- No history of stroke or TIA
- Statins, antihypertensives, ASA treatment OK
Key exclusion criteria (8 listed)
- History of CAD, CABG, PTCA, coronary or peripheral stenting
- History of stroke/TIA/peripheral vascular disease
- Inability to exercise on the treadmill
- Unwilling/unable to sign informed consent
- History of neck radiation or neck surgery or inability to obtain neck images
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 Intima-Media Thickness (CIMT) | Other | Stress Echocardiography (SE) |
Primary outcome
% Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram
Time frame: Baseline
We are comparing the % of patients with abnormal IMT defined as presence of plaque (= or >1.5mm) or CIMT >75% percentile for age, race, and gender compared to % of patients with positive ischemia on stress echocardiogram as defined by a new wall motion abnormality on echocardiogram with stress.
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 3 May 2023.
- Mayo Clinic Clinical TrialsLink 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.
Tasneem Naqvi, MD principal investigator
Mayo Clinic
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 Cardiovascular Risk Stratification and Carotid Intima-media Thickness (CIMT), run by Mayo Clinic 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 5 inclusion and 8 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 3 May 2023. 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?
% Patients w/ Abnormal IMT vs. % Patients w/ Positive Ischemia on Stress Echocardiogram (time frame: Baseline). 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 3 May 2023.