A Perspective, Self-control Study on the Progression of Carotid Plaques in Anti-PD-1 mAb Treated Tumor Patients by Artery Ultrasound Follow-up

NCT05123287 | Unknown DMC

• 1 other identifier: 2019-221
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Plaque, Atherosclerotic; Immune Checkpoint Inhibitors; Programmed Cell Death Protein 1 Inhibitor; Carotid Artery Plaque; Intimal Medial Thickness of Internal Carotid Artery

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  3 months

Interventions

PD-1 immune checkpoint blockades DRUG

intravenous injection; frequency: 2-3 weeks/cycle; duration: 3 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population are the PD-1 immune checkpoint blockade treated tumor patients from 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China.

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

Related Publications (8)

• Spence JD. Measurement of carotid plaque burden. JAMA Neurol. 2015 Apr;72(4):383-4. doi: 10.1001/jamaneurol.2014.3002. No abstract available.

  PMID: 25686472 BACKGROUND

• O'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.

  PMID: 9878640 BACKGROUND

• Spence 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.

  PMID: 12468791 RESULT

• Lorenz 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.

  PMID: 22541275 RESULT

• Polak 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.

  PMID: 21774709 RESULT

• Saba 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.

  PMID: 30954372 RESULT

• Lechareas 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.

  PMID: 26493239 RESULT

• Sakaguchi 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.

  PMID: 12706187 RESULT

MeSH Terms

Conditions

Plaque, Atherosclerotic; Carotid Stenosis; Carotid Intimal Medial Thickness 1

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianan Wang, MD, PhD

  2nd Affiliated Hospital, School of Medicine at Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianan Wang, MD, PhD

CONTACT

+86 0571 87784808; wangjianan111@zju.edu.cn

Lin Fan, PhD

CONTACT

+86 13656691938; fanlin@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: November 17, 2021
• Study Start: October 8, 2021
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-10

Locations

CN (1)