The objective of this study is to compare coronary artery plaque characteristics between non-invasive MSCT, and invasive IVUS and OCT in patients presenting with ACS without ST-elevation (non-ST elevation myocardial infarction (NSTEMI)).
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The accuracy of coronary plaque characterization with MSCT as compared to IVUS
and OCT will be investigated. In addition, the correlation between plaque
characteristics and clinical characteristics (gender and diabetes) will be
explored.
Secondary outcome
not applicable
Background summary
Multi-slice computed tomography (MSCT) enables non-invasive coronary plaque
characterization. Potentially, non-invasive MSCT may improve risk
stratification. Intravascular ultrasound (IVUS) and optical coherence
tomography (OCT) allow invasive and more accurate characterization of coronary
atherosclerotic plaques as compared to MSCT, and accordingly may enhance our
understanding on plaque imaging with MSCT. A high correlation between coronary
plaque composition was observed between MSCT and IVUS. Nevertheless, the data
on comparison of coronary plaque characteristics between non-invasive MSCT and
OCT in particular in patients presenting with acute coronary syndromes (ACS)
are scarce.
Study objective
The objective of this study is to compare coronary artery plaque
characteristics between non-invasive MSCT, and invasive IVUS and OCT in
patients presenting with ACS without ST-elevation (non-ST elevation myocardial
infarction (NSTEMI)).
Study design
Single-center, prospective, observational study.
Intervention
The participants will undergo extra examinations. 1) A MSCT examination
preliminary of the percutaneous coronary intervention; and 2) during the
percutaneous coronary intervention a IVUS and OCT examination.
Study burden and risks
Based on currently available clinical evidence, risks related to the devices
used in this study are comparable to standard equipment used. Dual source MSCT
is performed in routine clinical practice and is considered as safe,
non-invasive investigation, although it involves administration of contrast
medium, and the use of radiation. Accordingly, only patients with good kidney
function and with no prior history of allergy to contrast agents will be
included in the study. The MSCT study protocols with the least possible
radiation exposure will be applied, so that exposure favourably compares to
other non-invasive clinical investigations (such as myocardial perfusion
scintigraphy).
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
- Chest pain suggestive for myocardial ischemia for at least 30 minutes;
- Electrocardiogram (ECG) with ST-segment shifts (ST-segment depression >1 mm in at least two contiguous leads or transient ST-segment elevation > 1mm with duration of < 30 min in at least two contiguous leads) and/or T-wave changes (T-wave inversion > 1.5 mm in at least three contiguous leads);
- Positive hs Troponin T > 14 ng/L or positive Troponin T <0.01 µg/L
- Clinical indication for invasive coronary angiography followed by PCI of the ischemia-related target lesion;
- Informed consent.
Exclusion criteria
- Persistent ST-elevation of >1 mm in 2 or more leads;
- Need for emergency invasive coronary angiography and PCI;
- Need for emergency coronary artery bypass grafting;
- Presence of cardiogenic shock;
- Estimated glomerular filtration rate (eGFR) < 50 ml/min;
- Known allergy to iodine contrast agents;
- Cardiac rhythms other than sinus rhythm;
- Inability to lay supine;
- Inability tot sustain a breath-hold for 15 seconds;
- Inability to provide informed consent.
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 | NL33521.042.10 |