Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519292
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ITHACA
Brief Summary:
Immune checkpoint inhibitors ICI have revolutionized cancer treatment and are now approved for various types of cancer The most common side effects of ICI are immune-related adverse events which can affect any organ or system in the body Recently concerns have also risen about cardiovascular effects of ICI Retrospective studies showed an 4-5 times increased risk of developing an arterial thromboembolic event
The mechanisms driving the ICI-associated risks of arterial thromboembolic events such as myocardial infarction and stroke are unclear Since the risk of a thromboembolism appears to be increased already during the first months after initiation of ICI immune-related hypercoagulability or autoimmune antiphospholipid antibodies may play a role but data to support this are lacking The longer-term risk of arterial thromboembolism may be predominantly driven by accelerated atherosclerosis a chronic low-grade inflammatory disease of the larger arteries Therefore we assess the effect of ICI on progression of coronary non-calcifid plaque volume by using computed tomography angiography CCTA
The mechanisms driving the ICI-associated risks of arterial thromboembolic events such as myocardial infarction and stroke are unclear Since the risk of a thromboembolism appears to be increased already during the first months after initiation of ICI immune-related hypercoagulability or autoimmune antiphospholipid antibodies may play a role but data to support this are lacking The longer-term risk of arterial thromboembolism may be predominantly driven by accelerated atherosclerosis a chronic low-grade inflammatory disease of the larger arteries Therefore we assess the effect of ICI on progression of coronary non-calcifid plaque volume by using computed tomography angiography CCTA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None