Plaque, AtheroscleroticNCT05123287
A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
An observational study of Plaque, Atherosclerotic and Immune Checkpoint Inhibitors, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Plaque, Atherosclerotic, Immune Checkpoint Inhibitors, Programmed Cell Death Protein 1 Inhibitor
- What is being tested?
- PD-1 immune checkpoint blockades
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2021to 1 Dec 2022
- How long will I take part?
- 3 Months
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Study population are the PD-1 immune checkpoint blockade treated tumor patients from 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China.
Who may be able to join
- The age of subjects are between 18-90 years old (including 18 and 90 years old);
- All kinds of tumor diseases of subjects are acceptable;
- All kinds of PD-1 immune checkpoint blockades or dosages are acceptable;
- The subjects knew about the experiment and signed the informed consent voluntarily;
- The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months;
- The subjects complicated with atherosclerotic carotid plaques.
Who cannot join
- Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up;
- Subjects are reluctant to continue to be involved in this study;
- Known pregnant and lactating women;
- The parameters (e.g., CCA intima-media, ICA intima-media or carotid plaque burden) could not be calculated because of the quality of ultrasound image;
- Other situations that the researchers judged were not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310003
Lin Fan, PhD, 86-13656691938, fanlin@zju.edu.cn
About this study
A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Read the detailed description
This is a perspective, self-controlled cohort study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs (PD-1 immune checkpoint blockades) on atherosclerotic carotid plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the: ① The mean intima-media thickness of the common carotid artery (Mean CCA thickness); ② The maximum intima-media thickness of the internal carotid artery (maximum ICA thickness); ③ Carotid plaque burden: by calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the above-mentioned parameters at the same location of carotid artery in each patient when initiate the first-dose of anti-PD-1 mAbs therapy and 3 months post anti-PD-1 mAbs therapy. It is designed to assess the effectiveness of anti-PD-1 mAbs on the progression of carotid plaques.
- Conditions
- Plaque, Atherosclerotic, Immune Checkpoint Inhibitors, Programmed Cell Death Protein 1 Inhibitor, Carotid Artery Plaque, Intimal Medial Thickness of Internal Carotid Artery
- Being tested
- PD-1 immune checkpoint blockades
- Medical subject headings
- Plaque, Atherosclerotic, Carotid Stenosis, Carotid Intimal Medial Thickness 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 immune checkpoint blockadesDrug
intravenous injection; frequency: 2-3 weeks/cycle; duration: 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean intima-media thickness of the common carotid artery
It was measured over a segment of the common carotid artery that was 1 cm long, located approximately 0.5 cm below the carotid-artery bulb, and considered not to contain any plaque (i.e., not to have any perceivable protrusion of the artery wall into the lumen).
Measured: 3 months
The maximum intima-media thickness of the internal carotid artery
It was defined as the greatest intima-media thickness in either the right or left internal carotid artery extending from the bulb to 1 cm above the carotid sinus, ascertained from a total of four views on each side.
Measured: 3 months
Carotid plaque burden
Carotid plaque area measured by ultrasound (cross-sectional area of longitudinal views of all plaques seen) to quantify the increase or decrease of atherosclerotic carotid plaques.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start8 Oct 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Plaque, AtheroscleroticStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianan Wang, MD, PhD, Principal investigator, 2nd Affiliated Hospital, School of Medicine at Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05123287
- Sponsor's protocol ID
- 2019-221
- Status last verified
- Oct 2021
- First submitted
- 9 Sep 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spence JD. Measurement of carotid plaque burden. JAMA Neurol. 2015 Apr;72(4):383-4. doi: 10.1001/jamaneurol.2014.3002. No abstract available.
PubMed 25686472O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22. doi: 10.1056/NEJM199901073400103.
PubMed 9878640Spence JD, Eliasziw M, DiCicco M, Hackam DG, Galil R, Lohmann T. Carotid plaque area: a tool for targeting and evaluating vascular preventive therapy. Stroke. 2002 Dec;33(12):2916-22. doi: 10.1161/01.str.0000042207.16156.b9.
PubMed 12468791Lorenz MW, Polak JF, Kavousi M, Mathiesen EB, Volzke H, Tuomainen TP, Sander D, Plichart M, Catapano AL, Robertson CM, Kiechl S, Rundek T, Desvarieux M, Lind L, Schmid C, DasMahapatra P, Gao L, Ziegelbauer K, Bots ML, Thompson SG; PROG-IMT Study Group. Carotid intima-media thickness progression to predict cardiovascular events in the general population (the PROG-IMT collaborative project): a meta-analysis of individual participant data. Lancet. 2012 Jun 2;379(9831):2053-62. doi: 10.1016/S0140-6736(12)60441-3. Epub 2012 Apr 27.
PubMed 22541275Polak JF, Pencina MJ, Pencina KM, O'Donnell CJ, Wolf PA, D'Agostino RB Sr. Carotid-wall intima-media thickness and cardiovascular events. N Engl J Med. 2011 Jul 21;365(3):213-21. doi: 10.1056/NEJMoa1012592.
PubMed 21774709Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019 Jun;18(6):559-572. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4.
PubMed 30954372Lechareas S, Yanni AE, Golemati S, Chatziioannou A, Perrea D. Ultrasound and Biochemical Diagnostic Tools for the Characterization of Vulnerable Carotid Atherosclerotic Plaque. Ultrasound Med Biol. 2016 Jan;42(1):31-43. doi: 10.1016/j.ultrasmedbio.2015.09.003. Epub 2015 Oct 20.
PubMed 26493239Sakaguchi M, Kitagawa K, Nagai Y, Yamagami H, Kondo K, Matsushita K, Oku N, Hougaku H, Ohtsuki T, Masuyama T, Matsumoto M, Hori M. Equivalence of plaque score and intima-media thickness of carotid ultrasonography for predicting severe coronary artery lesion. Ultrasound Med Biol. 2003 Mar;29(3):367-71. doi: 10.1016/s0301-5629(02)00743-3.
PubMed 12706187
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
- ClinicalTrials.gov ID
- NCT05123287
- Acronym / sponsor ID
- 2019-221
- Conditions
- Plaque, Atherosclerotic, Immune Checkpoint Inhibitors, Programmed Cell Death Protein 1 Inhibitor, Carotid Artery Plaque, Intimal Medial Thickness of Internal Carotid Artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 17 Nov 2021 (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.
A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up
Detailed description
This is a perspective, self-controlled cohort study. This study aims to evaluate the effectiveness of anti-PD-1 mAbs (PD-1 immune checkpoint blockades) on atherosclerotic carotid plaques in those anti-PD-1 mAbs treated patients. The method for quantification and evaluation of atherosclerotic plaques are based on the: ① The mean intima-media thickness of the common carotid artery (Mean CCA thickness); ② The maximum intima-media thickness of the internal carotid artery (maximum ICA thickness); ③ Carotid plaque burden: by calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. By comparing the above-mentioned parameters at the same location of carotid artery in each patient when initiate the first-dose of anti-PD-1 mAbs therapy and 3 months post anti-PD-1 mAbs therapy. It is designed to assess the effectiveness of anti-PD-1 mAbs on the progression of carotid plaques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population are the PD-1 immune checkpoint blockade treated tumor patients from 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China.
Key inclusion criteria (6 listed)
- The age of subjects are between 18-90 years old (including 18 and 90 years old);
- All kinds of tumor diseases of subjects are acceptable;
- All kinds of PD-1 immune checkpoint blockades or dosages are acceptable;
- The subjects knew about the experiment and signed the informed consent voluntarily;
- The subjects plan to receive PD-1 immune checkpoint blockades and potentially to be treated for over 3 months;
Key exclusion criteria (5 listed)
- Subjects stop receiving or changing the PD-1 immune checkpoint blockades during follow-up;
- Subjects are reluctant to continue to be involved in this study;
- Known pregnant and lactating women;
- The parameters (e.g., CCA intima-media, ICA intima-media or carotid plaque burden) could not be calculated because of the quality of ultrasound image;
- Other situations that the researchers judged were not suitable for inclusion.
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 |
|---|---|---|
| PD-1 immune checkpoint blockadesintravenous injection; frequency: 2-3 weeks/cycle; duration: 3 months | Drug | – |
Primary outcome
The mean intima-media thickness of the common carotid artery
Time frame: 3 months
It was measured over a segment of the common carotid artery that was 1 cm long, located approximately 0.5 cm below the carotid-artery bulb, and considered not to contain any plaque (i.e., not to have any perceivable protrusion of the artery wall into the lumen).
The maximum intima-media thickness of the internal carotid artery
Time frame: 3 months
It was defined as the greatest intima-media thickness in either the right or left internal carotid artery extending from the bulb to 1 cm above the carotid sinus, ascertained from a total of four views on each side.
Carotid plaque burden
Time frame: 3 months
Carotid plaque area measured by ultrasound (cross-sectional area of longitudinal views of all plaques seen) to quantify the increase or decrease of atherosclerotic carotid plaques.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
- Background: PubMed 25686472Spence JD. Measurement of carotid plaque burden. JAMA Neurol. 2015 Apr;72(4):383-4. doi: 10.1001/jamaneurol.2014.3002. No abstract available.
- Background: PubMed 9878640O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22. doi: 10.1056/NEJM199901073400103.
- Results publication: PubMed 12468791Spence JD, Eliasziw M, DiCicco M, Hackam DG, Galil R, Lohmann T. Carotid plaque area: a tool for targeting and evaluating vascular preventive therapy. Stroke. 2002 Dec;33(12):2916-22. doi: 10.1161/01.str.0000042207.16156.b9.
- Results publication: PubMed 22541275Lorenz MW, Polak JF, Kavousi M, Mathiesen EB, Volzke H, Tuomainen TP, Sander D, Plichart M, Catapano AL, Robertson CM, Kiechl S, Rundek T, Desvarieux M, Lind L, Schmid C, DasMahapatra P, Gao L, Ziegelbauer K, Bots ML, Thompson SG; PROG-IMT Study Group. Carotid intima-media thickness progression to predict cardiovascular events in the general population (the PROG-IMT collaborative project): a meta-analysis of individual participant data. Lancet. 2012 Jun 2;379(9831):2053-62. doi: 10.1016/S0140-6736(12)60441-3. Epub 2012 Apr 27.
- Results publication: PubMed 21774709Polak JF, Pencina MJ, Pencina KM, O'Donnell CJ, Wolf PA, D'Agostino RB Sr. Carotid-wall intima-media thickness and cardiovascular events. N Engl J Med. 2011 Jul 21;365(3):213-21. doi: 10.1056/NEJMoa1012592.
- Results publication: PubMed 30954372Saba L, Saam T, Jager HR, Yuan C, Hatsukami TS, Saloner D, Wasserman BA, Bonati LH, Wintermark M. Imaging biomarkers of vulnerable carotid plaques for stroke risk prediction and their potential clinical implications. Lancet Neurol. 2019 Jun;18(6):559-572. doi: 10.1016/S1474-4422(19)30035-3. Epub 2019 Apr 4.
- Results publication: PubMed 26493239Lechareas S, Yanni AE, Golemati S, Chatziioannou A, Perrea D. Ultrasound and Biochemical Diagnostic Tools for the Characterization of Vulnerable Carotid Atherosclerotic Plaque. Ultrasound Med Biol. 2016 Jan;42(1):31-43. doi: 10.1016/j.ultrasmedbio.2015.09.003. Epub 2015 Oct 20.
- Results publication: PubMed 12706187Sakaguchi M, Kitagawa K, Nagai Y, Yamagami H, Kondo K, Matsushita K, Oku N, Hougaku H, Ohtsuki T, Masuyama T, Matsumoto M, Hori M. Equivalence of plaque score and intima-media thickness of carotid ultrasonography for predicting severe coronary artery lesion. Ultrasound Med Biol. 2003 Mar;29(3):367-71. doi: 10.1016/s0301-5629(02)00743-3.
- Individual participant dataSharing planned: Undecided
Related trials for Plaque, Atherosclerotic
RecruitingPhase 3
A Study to See if Lepodisiran Can Reduce Plaque in Coronary Arteries of Adults With Elevated Lp(a) Who Have Had Heart Events or Are at High Risk
Atherosclerosis, Cardiovascular Diseases
RecruitingObservational study
Coronary Myocardial Bridge and Coronary Plaques on MDCT
Myocardial Bridging, Coronary Atherosclerosis
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
Active, not recruitingPhase 4
Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Not yet recruiting
PREventive Invasive Strategy for Obstructive Coronary Artery Disease With Vulnerable Plaque Evaluated by CoroNary Computed Tomography Angiography-2
Coronary Artery Disease
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.
Jianan Wang, MD, PhD principal investigator
2nd Affiliated Hospital, School of Medicine at Zhejiang 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 Plaque, Atherosclerotic and Immune Checkpoint Inhibitors, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Nov 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianan Wang, MD, PhD (+86 0571 87784808, wangjianan111@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean intima-media thickness of the common carotid artery (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05123287, which also lists 8 linked publications.
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 17 Nov 2021.