To determine the diagnostic performance of high-pitch CCTA and dynamic CTP for the diagnosis of myocardial ischemia using invasive coronary indices as the reference standard.
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
To assess the diagnostic performance in terms of sensitivity, specificity,
negative predictive value (NPV), positive predictive value (PPV) and diagnostic
accuracy of high-pitch CCTA and dynamic CTP for the diagnosis of significant
CAD as defined by an FFR <=0.80 in patients with a history of CAD.
Secondary outcome
(1) To compare the diagnostic capabilities of high pitch CCTA and dynamic CTP
to detect significant CAD when defined by instantaneous wave-free ratio (iFR).
(2) To investigate the potential of high-pitch CCTA to improve plaque
characterization and as such diagnosis of ischemia - due to mounting evidence
suggesting a relationship between adverse plaque characteristics and ischemia -
and prognosis.
(3) To evaluate the prognostic value of high-pitch CCTA and dynamic CTP.
Background summary
Recent development in computed tomography (CT) hardware have fulfilled the
prerequisites for clinical CT myocardial perfusion imaging (CTP). Cardiac CT,
has by means of coronary computed tomography angiography (CCTA) and novel
techniques such as CTP the unique ability to provide information on both the
anatomical and functional severity of coronary artery disease (CAD). However,
diagnostic performance of these novel techniques when referenced by the
clinical diagnostic standard, invasive fractional flow reserve (FFR)
measurements, has scarcely been investigated in patients with a prior PCI for
stable CAD.
Study objective
To determine the diagnostic performance of high-pitch CCTA and dynamic CTP for
the diagnosis of myocardial ischemia using invasive coronary indices as the
reference standard.
Study design
The study is a single-center prospective comparative trial in which all
patients will undergo high-pitch CCTA and dynamic CTP before invasive coronary
angiography (ICA) in conjunction with invasive flow/pressure measurements.
Study burden and risks
A two day protocol will be completed after referral ensuring the diagnostic
work-up of patients is not delayed. On day 1 patients will undergo CCTA and
CTP. Then, on day 2, irrespective of CT results, patients will undergo ICA with
invasive pressure measurements. The risks of CT are considered to be low.
Patients are referred for a clinically indicated ICA and as such risks of the
ICA are not deemed study-related. However, CCTA and dynamic CTP imaging require
radiation. The estimated combined radiation dose for CCTA and dynamic CTP will
be ~12-13 mSv. Also, Dynamic CTP and CCTA require the use of iodinated
contrast. Reactions to contrast material may occur. Overall, the reported
incidence of adverse events with low-osmolar iodinated contrast is 1.5 events
per 1000 doses (2.62% of which are serious). Patients are referred for a
clinically indicated ICA and as such risks of the ICA are not deemed
study-related. Regarding the CCTA, patients with a heart rate above 65 per
minute can be given metoprolol. Side effects of this are low blood pressure and
dizziness. Nitroglycerin is also given before the CCTA. This can cause a
headache. Adenosine is given prior o the CTP. Side effects of this are rhythm
disturbances (including AV block) and skips.
Future patients might benefit from the present study as combined anatomical
information (CCTA) and functional information (dynamic CTP) obtained within one
scan-protocol might lead to a more judicious referral for ICA which leads to a
reduction of exposure to the possible unnecessary risk of an invasive
procedure. In addition, CT is a cost-effective technique in comparison with
invasive coronary angiography. Cardiac CT as a non-stop-shop will allow all
centers to perform anatomical and perfusion imaging in one session and will
spare patients to be referred to tertiary centers for state-of-the-art imaging.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- History of PCI for stable CAD
- Referred for a diagnostic ICA.
- Age above 35 years.
Exclusion criteria
- History of severe COPD or chronic asthma
- Pregnancy
- Renal failure (eGFR <30 mL/min)
- Use of sildenafil (Viagra) or dipyramidol (Persantin) that cannot be
terminated
- Contra-indications for β-blockers
- Allergic reaction to iodized contrast
- Concurrent or prior (within last 30 days) participation in other research
studies using investigational drugs
- Claustrophobia
- Significant co-morbidities
- Atrial fibrillation, second or third degree atrioventricular block
- Tachycardia
- Acute myocardial infarction (STEMI/NSTEMI)
- History of CABG
- Patients with a history of coronary chronic total occlusion
- LVEF estimated <50%
- Cardiomyopathies
- Previous radiation exposure in the diagnostic work-up
- Unable to give informed consent
- Indispensable follow-up with (serial) CT scans for non-cardiac related
condition
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 | NL76256.029.21 |