An observational study in Atherosclerotic Disease, Plaque, Atherosclerotic and Heart Diseases, sponsored by Pieter Muntendam. Status unknown at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by Pieter Muntendam · Observational
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Among 19 studies in Plaque, Atherosclerotic with a site in United States — 1 open to participants now, 4 under way, 2 of them phase 3. Plaque, Atherosclerotic · United States.
Among the 19 studies in Plaque, Atherosclerotic with a site in United States, this one is one of 3 that started in 2017, is one of 5 observational ones, and was the 14th registered.
105 studies on the registry are indexed under Plaque, Atherosclerotic; 27 are open to participants now.
Browse Plaque, Atherosclerotic studies →1 of the 19 studies in Plaque, Atherosclerotic with a site in United States is open now. Recruiting first, the newest first:
Ischemia Care LLC · Sites in United States
Ages 18–80
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 16 Plaque, Atherosclerotic studies recruiting now, 7 (44%) set no upper age limit and 4 (25%) stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 1 · Phase 3 6 · Phase 4 4
First in 2001; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,000 is above the median of 146 across 50 observational studies indexed under Plaque, Atherosclerotic.
Median enrollment 259 across the 14 interventional studies, 230 across the 5 observational. Of the 13 that completed or were terminated, 6 (46%) have results posted.
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5 of 19 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Pieter Muntendam as lead sponsor.
Pieter Muntendam has 1 study filed under Plaque, Atherosclerotic — fewer than ten, so there is no comparison to draw.
2 of the studies in Plaque, Atherosclerotic with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06305559Phase 3NewAmsterdam PharmaA CCTA Imaging Trial to Evaluate the Effect of Obicetrapib/Ezetimibe on Coronary Plaque | 2027-11 |
| NCT04063709University of North Carolina, Chapel HillTranscutaneous ARFI Ultrasound for Differentiating Carotid Plaque With High Stroke Risk | 2027-08 |
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Among the 19 studies in Plaque, Atherosclerotic with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This proposed follow-up study aims to recruit participants from the original BioImage cohort for a one-time follow-up examination. The repeat ultrasound scan of the carotid arteries will provide information on the natural history of carotid atherosclerosis and factors that contribute to plaque progression. Renewal of the HIPAA authorization will also be sought for 5 years to continue to monitor claims and other information for major cardiovascular events, other outcomes and healthcare utilization.
The design and objectives of the BioImage study (NCT00738725) have been published in detail. In brief, the BioImage study is investigating whether imaging of target arteries for subclinical atherosclerosis and measurement of ABI and circulating biomarkers add to the predictive value of traditional risk factor scoring systems, namely, the Framingham Risk Score. Enrollment in the BioImage study (January 2008 to June 2009) resulted in inclusion of 7,687 asymptomatic Americans ages 55 to 80 years from the Humana Health System resident in Chicago, Illinois, or Fort Lauderdale, Florida. Of these, 6,104 entered the imaging arm of the study. Analysis of the BioImage study cross- sectional baseline findings has yielded important novel findings related to presence and severity of subclinical atherosclerosis and the role of markers of subclinical disease to identify those at elevated risk for near-term atherothrombotic events.
One of the striking novel findings in the BioImage study was the prevalence of subclinical atherosclerotic disease in the carotid arteries as determined by a novel 3D ultrasound method. 3D carotid imaging was used to identify lesions located in the cervical part of the common carotid arteries (CCA) and internal carotid artery. 3D carotid imaging was initially performed using a high- resolution, linear array 2-dimensional transducer and scanning the artery in cross-section, slowly moving the transducer manually in the cranial direction from the proximal CCA into the distal internal carotid artery (i.e., from the clavicle to jawbone). The resulting 10-s digital video clip of this "manual 3D" cross-sectional sweep was examined in the core ultrasound laboratory for the presence and quantification of plaque. In the second phase of the study an electromechanical transducer was used to accomplish a similar sweep, replacing the manual sweep with a controlled movement of the transducer.
This ultrasound technique identified carotid plaques in 78% of cases. Carotid plaque burden was found to correlate stronger with CACS (chi-square 450, p \< 0.0001) than did cIMT (chi-square 24, p \< 0.0001)15. Analyses have indicated that subclinical atherosclerosis as determined by 3D ultrasound is an important risk factor with marked incremental value over conventional risk-factor based scores such as the Framingham Risk Score.
A total of 6,104 participants of the BioImage study were included in the baseline carotid ultrasound investigations. All of the original participants will be evaluated for study inclusion. It is expected that due to death, relocation, admission to nursing homes, disabilities, approximately 3,000 subjects will be available for recruitment for this study. This study aims to re-evaluate the maximum number of participants available with the available resources.
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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.
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.
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.
To investigate natural history of subclinical atherosclerosis as determined by 3D carotid ultrasound.
Device: Ultrasound 3D Imaging
Carotid artery ultrasound will be used to: Determine plaque presence and plaque burden Presence of stenosis Additionally, Carotid Intima-Media Thickness (IMT) will be measured and aortic diameter will be measured by abdominal aortic ultrasound scanning. Ultrasound of the Abdominal Aorta will be used to determine the presence and severity of stenosis or aneurism.
To investigate natural history of subclinical atherosclerosis as determined by 3D carotid ultrasound.
Time frame: 5 Years
To evaluate the role of risk factors in disease progression of subclinical atherosclerosis.
Time frame: 5 Years
To assess persistence of risk factors over an approximately 5-year time span between the baseline and the planned follow-up evaluation.
Time frame: 5 Years
Started Sep 2017 (actual). Primary completion is estimated for Sep 2018, 12 months after the start.
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 planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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