Immune checkpoint inhibition associated cardiovascular adverse events in cancer patients

Recruiting

• Conditions: 10014523; cardiovascular disease (CVD); heart and vascular disease; 10011082; 10027655

• Registration Number: NL-OMON51839
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 214

Inclusion Criteria

- Adult male or female, age >=50 years
- Prior to start therapy
- Confirmed diagnosis of cancer:
- Treatment-naive advanced esophageal, gastric, or gastro-esophageal cancer
planned for first-line nivolumab or chemotherapy only or follow-up only after
resection
- Treatment-naive advanced colorectal cancer planned for first-line
pembrolizumab or other systemic therapies
- Recurrent or metastatic head/neck squamous cell carcinoma with disease
progression during platinum-based chemotherapy who are planned for
pembrolizumab or other systemic therapies
- Non-small-cell lung carcinoma planned for pembrolizumab or durvalumab or
other systemic therapies
- Advanced renal cell carcinoma planned for first-line ipilimumab/nivolumab or
other systemic therapies
- Inresectible or advanced melanoma planned for ipilimumab/ nivolumab

Exclusion Criteria

• ICI therapy in previous 12 months;
• Suspected or confirmed viral, fungal, or bacterial infectious disease;
• Use of immunosuppressive therapy prior to ICI start;
• Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2;
• Known allergy to iodinated contrast agents;
• Atrial fibrillation

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameter: absolute total coronary plaque volume progression</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary parameters:<br /><br>- CCTA (coronair): plaque progression and plaque characteristics<br /><br>(vulnerability)<br /><br>- CTA carotid): plaque progression and plaque characteristics (vulnerability)<br /><br>- Clinical outcomes: cardiovacular disease events (i.g. myocardial infarction,<br /><br>stroke), venous thromboembolism, immune related adverse events, death of any<br /><br>cause</p><br>