1. To determine the change in plaque characteristics of non-culprit LRPs, as measured with IVUS/NIRS, after treatment with DEB in patients with ACS.2. To develop a non-invasive algorithm that is able to detect LRPs with CT.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in LCBImm4 between baseline and 9 months
Secondary outcome
* Changes in plaque volume and characteristics of LRPs treated with DEB
measured by CTCA at 9-month follow-up, as compared to baseline;
* Changes in perivascular fat as measured by CTCA at 9-month follow-up, as
compared to baseline;
* Flow-limiting dissection necessitating bail-out stent implantation;
* Periprocedural myocardial infarction;
* LRP lesion failure, defined as cardiac death, myocardial infarction, or
ischemia-driven revascularization related to an identified non-culprit LRP
lesion up to one-year follow-up;
* Patient-oriented composite outcomes, defined as all-cause mortality,
myocardial infarction, or any repeat revascularization up to one-year follow-up;
* Additional IVUS + NIRS lesion characteristics (plaque volume, minimal lumen
area);
* Correlation of vulnerable plaque characteristics on CTCA with IVUS + NIRS at
9-months follow-up.
Background summary
Two-thirds of intracoronary thrombi causing acute coronary syndrome (ACS)
result from rupture of lipid-rich plaques (LRP). After treatment of the culprit
lesion in ACS patients, additional LRPs are found in approximately 50% of
patients. 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
and treatment of LRPs, providing reduced disease burden, and generate insight
into the underlying pathogenesis. It is currently unknown whether treatment of
LRPs leads to plaque stabilization, potentially reducing the number of
subsequent ACS. We hypothesize that LRPs can be treated with balloons coated
with an antiproliferative drug (i.e. drug-eluting balloons; DEB) to deliver
both mechanical and selective pharmacotherapeutic treatment to halt the local
atherosclerotic process.
Study objective
1. To determine the change in plaque characteristics of non-culprit LRPs, as
measured with IVUS/NIRS, after treatment with DEB in patients with ACS.
2. To develop a non-invasive algorithm that is able to detect LRPs with CT.
Study design
Prospective single-arm clinical trial
Intervention
If an LRP is detected with IVUS/NIRS, these are treated with DEB
Study burden and risks
Patients participating in this study are exposed to extra measurements during
their primary intervention for ACS, as well as an extra coronary angiography
after 9 months. Moreover, patients undergo CTCA at baseline and 9 months.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1. Patient has an acute coronary syndrome without ST-segment elevation on the
ECG (NSTE-ACS), including non-ST-elevation myocardial infarction and unstable
angina pectoris.
2. An invasive revascularization strategy for NSTE-ACS with PCI is chosen.
3. The coronary arteries are open and patent on CTCA, thus feasible to scan all
major coronary arteries with IVUS/NIRS.
Exclusion criteria
Angiographic exclusion criteria:
1. Patient has additional lesions that cannot be treated during the index PCI
and need staged PCI;
2. A chronic total occlusion is present;
3. Previous coronary artery bypass-grafting;
4. Patient has a major procedural complication of the index PCI (coronary
perforation, coronary dissection);
Clinical exclusion criteria:
5. Irregular heart rhythm, affecting the CT quality (i.e. atrial fibrillation
or frequent premature ventricular contractions);
6. Technical aspects hampering appropriate CT assessment (i.e. the presence of
extreme calcifications or extreme tortuosity);
7. Unstable patients (the presence of cardiogenic shock, need for intubation,
need for inotropes);
8. Patients with ST-segment elevations on the ECG requiring immediate primary
PCI;
9. Body weight > 250 kg;
10. Known renal insufficiency (estimated Glomerular Filtration Rate [eGFR] <30
mL/min/1.73m2 or subject on dialysis);
11. Hypersensitivity or allergy to contrast with inability to properly
pre-hydrate;
12. Presence of a comorbid condition with a life expectancy of less than one
year;
13. Participation in another trial;
14. Subject is belonging to a vulnerable population (per investigator*s
judgment, e.g., subordinate hospital staff) or is unable to read or write.
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 | NL73933.018.20 |