The proposed project will have the following objectives:1. To investigate the correlation between 18F-FDG accumulation in plaques seen on PET-CT and plaque characteristics found with IVUS-VH and OCT.2. To investigate the correlation between…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Correlation between Target-to-Background Ratios (TBRs) and necrotic core in
contact with lumen (NCCL) / Plaque Burden (PB) measured with IVUS.
2. Correlation between TBRs and fibrous, fibrolipidic, necrotic core, or
calcium content of plaques found with IVUS in every ROI.
3. Correlation between TBRs and macrophage quantification / cap thickness on
OCT in every ROI.
4. Correlation in median and max TBR between coronary arteries and the other
investigated arteries.
Secondary outcome
1. Correlation between biomarkers and macrophage quantification/ cap thickness
on OCT.
2. Correlation between biomarkers and max TBR on PET-CT.
3. Correlation between NCCL, PB, plaque content found with IVUS-VH and cap
thickness found on OCT.
Background summary
Acute coronary syndrome (ACS) is often the first clinical presentation of
atherosclerosis. Angiographic and clinical findings are poor predictors of ACS.
This has led to the development of the concept of vulnerable plaque: a plaque
which is prone to rupture or highly thrombogenic, and therefore carries a high
risk of causing ACS. As a consequence, a considerable patient population with
subclinical coronary artery disease (CAD) is at risk of developing ACS in the
near future. The ultimate goal in the field of ACS is the detection of
vulnerable plaques even before ACS develops, which may create the possibility
to prevent ACS with medical or interventional treatment. To achieve this, it is
of immensely importance to develop a method to detect vulnerable plaques
non-invasively. One important characteristic of a vulnerable plaque is active
inflammation as a result of extensive macrophage accumulation. PET-CT has shown
to be an excellent imaging modality to detect even small amounts of
inflammation. In this study, we will investigate whether PET-CT findings
correlate with characteristics of vulnerable plaques found with the invasive
methods intravascular ultrasound (IVUS) and optical coherence tomography
(OCT).
Study objective
The proposed project will have the following objectives:
1. To investigate the correlation between 18F-FDG accumulation in plaques seen
on PET-CT and plaque characteristics found with IVUS-VH and OCT.
2. To investigate the correlation between inflammation of the coronary arteries
and inflammation in other arteries (carotid, aortic and femoral arteries).
3. To evaluate the correlation between 18F-FDG accumulation in plaques and
serum biomarkers in all groups.
Study design
Patients are eligible for this study if they have a clinical indication for
percutaneous coronary intervention after they have been diagnosed with
non-ST-segment elevation myocardial infarction (NSTEMI) within the previous 5
days. Before any study-related procedure, written informed consent is obtained.
After coronary angiography, IVUS-VH and OCT measurements of the culprit lesion
is performed prior to PCI, except when ischemia is seen when IVUS-VH- or
OCT-catheters are passing the culprit lesion. If the PCI is successfully
performed, i.e. the remaining stenosis is less than 20 percent and no
dissection is made, patients undergo IVUS-VH and OCT, if suitable (at
discretion of the operator), in all three coronary arteries (including the
target vessel). As soon as possible, but at least within 72 hours after PCI,
patients will undergo 18F-FDG PET-CT. The findings of 18F-FDG PET-CT and
IVUS-VH/OCT will be analyzed and compared.
Study burden and risks
Patients are exposed to extra radiation burden due to injection of radio-active
glucose (18)F-FDG prior to PET scan, radiation due to low dose CT during
PET-CT, and the catheterization is elongated with 20minutes (although only a
couple of minutes extra fluorescence time). Because during the IVUS and OCT
assessment, extra catheters are placed in the coronary tree, there is a
slightly increas in the risk for dissection, or procedure related myocardial
infarction.
The burden associated with participation in this study consists of 2 times 20
minutes anamnesis, physical exam and EKG and elongation of the catheterization
with 20 minutes. The duration of the PET-CT (including preparation) will be
approximately 6 hours.
postbus 22660
1105AZ
NL
postbus 22660
1105AZ
NL
Listed location countries
Age
Inclusion criteria
Consecutive patients with symptoms of acute coronary syndromes without ST-segment
elevation are eligible for this study if the following three inclusion criteria apply:
a. One or more episodes of anginal symptoms at rest or at minimal exertion within the last 5 days, presumed to be ischemic in origin and lasting at least 5 minutes
b. Troponin or CKMB concentration above the upper reference limit
c. An indication for percutaneous coronary intervention (PCI) of a de novo culprit lesion with at least one non-culprit vessel with a 40mm proximal segment without stenoses of more 50%, suitable for IVUS and OCT
Exclusion criteria
a. Persistent ST-segment elevation of >1mm in two or more contiguous electrocardiographic leads
b. Impaired renal function (eGFR <60 mls/min/1,73 m2).
c. Hypotension (Systolic BP <90 mmHg), decompensated heart failure, shock, refractory ventricular arrhythmias, acute conduction system disease, implanted defibrillator, or left ventricular ejection fraction *30%.
d. Known allergies to aspirin, all thienopyridines (Plavix ®, Effient ®), heparin, stainless steel, copper or a sensitivity to contrast media which cannot be adequately pre-medicated.
e. Disabling stroke within the past year.
f. History of significant gastro-intestinal bleeding, bleeding diathesis or coagulopathy.
g. Any prior bypass graft surgery.
h. Prior or planned heart transplant or any other organ transplant.
i. Planned major non-cardiac (for example oncological) surgery.
j. Life expectancy of less than one year or factors making clinical follow-up difficult
k. Previous participation in this study or participation in another study with any investigational drug or device within the past 30 days (study participation ends after completion of the final follow-up).
l. Women who are pregnant or women of childbearing potential who do not use adequate contraception.
m. Patients known with diabetes mellitus.
n. Inability to comply with the specific follow -up evaluation
o. Restenosis of a (previously treated) culprit lesion
p. Untreated left main disease with > 50% stenosis.
q. Significant, diffuse 3-vessel coronary artery disease, requiring treatment.
r. Known tendency to coronary vasospasm.
s. Not possible to perform 18F-FDG PET-CT within 72 hours after PCI.
t. Persistent irregular heart rhythm
Design
Recruitment
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 | NL35482.018.11 |