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A prospective, observational, multicenter, cohort trial to evaluate the association between immune checkpoint inhibitors and coronary atherosclerosis in patients with malignant tumors complicated with coronary atherosclerotic heart disease.

A prospective, observational, multicenter, cohort trial to evaluate the association between immune checkpoint inhibitors and coronary atherosclerosis in patients with malignant tumors complicated with coronary atherosclerotic heart disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118171
Enrollment
Unknown
Registered
2026-02-03
Start date
2026-02-03
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant tumor

Interventions

Exposed group:None
Non-exposed group:None

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years old; 2. ECOG PS 0 or 1; 3. Patients with malignant tumors; 4. Already diagnosed with coronary atherosclerotic heart disease, and assessed as high-risk or above by the overall ASCVD risk assessment; 5. Able to comply with the protocol during the study period; 6. Provided written informed consent before entering the study, and the patient has understood that they can withdraw from the study at any time without any loss.

Exclusion criteria

Exclusion criteria: 1.Patients with severe heart, liver, kidney, lung and other important organ insufficiency; 2.Allergy to iodine or contrast media; 3.Severe water and electrolyte disorders; 4.Presence of coagulopathy; 5.Those who have gastrointestinal bleeding within two weeks prior to enrollment, or who are judged by the investigator to have a high risk of bleeding; 6.Presence of an underlying medical condition that, in the opinion of the investigator, is not conducive to the study; 7.Patients who have had an allogeneic stem cell transplant or organ transplant; 8.Patients treated with ICIs;

Design outcomes

Primary

MeasureTime frame
Change in plaque properties;

Secondary

MeasureTime frame
Major Adverse Cardiovascular Events;Plaque volume changes;Changes in LDL-C levels;Change in calcification integral;Change in plaque loading;

Countries

China

Contacts

Public ContactYao Zhifeng

Zhongshan Hospital, Fudan University

yao.zhifeng@zs-hospital.sh.cn+86 21 1866 1688

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026