To develop a non-invasive algorithm that allows the detection of LRPs with CTCA
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The ability of CTCA to detect a LRP (LCBImm4 > 400) as identified by NIRS
Secondary outcome
o The CTCA plaque characteristics of lipid-rich plaques (i.e. plaques with
LCBImm4 >400), as identified with NIRS.
o The CTCA characteristics of near-lipid-rich coronary plaques with LCBImm4 of
*250 and <400.
o To correlate the CTCA findings and IVUS findings of lipid-rich plaques
(LCBImm4 >400) and near-lipid-rich plaques (LCBImm4 between 250 and 400).
Background summary
Two-thirds of intracoronary thrombi causing acute coronary syndrome (ACS)
result from rupture of lipid-rich plaques (LRP). Near infrared spectroscopy
(NIRS) combined with intracoronary ultrasound (IVUS) can identify these
vulnerable plaques during coronary angiography (CAG) and is able to assess
plaque characteristics and the lipid-core burden index in a 4mm segment
(LCBImm4). Computed tomography coronary angiography (CTCA) may be an
alternative, non-invasive method to detect vulnerable plaques. This additional
imaging technique, combined with artificial intelligence-based analysis, could
contribute to earlier detection of LRPs, generating insight into the underlying
pathogenesis.
Study objective
To develop a non-invasive algorithm that allows the detection of LRPs with CTCA
Study design
Observational study
Study burden and risks
Patients will undergo additional 3-vessel IVUS-NIRS imaging, leading to an
additional extra 3 minutes in the cathlab, with a maximum of 1 minute extra
radiation and a maximum of 15 cc extra contrast.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Subject underwent computed tomography coronary angiography within the
previous two months;
2. Subject is scheduled for subsequent invasive coronary angiography.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. Acute coronary syndrome with ST-segment elevation;
2. Acute coronary syndrome without ST-segment elevation with hemodynamic
instability or ongoing ischemia, requiring urgent revascularization;
3. Estimated glomerular filtration rate <30 ml/min/1.73 m2;
4. Contrast allergy;
5. Subject is pregnant or breastfeeding.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76046.018.20 |