The objective of this study is three-fold: 1) Assess measurement settings and develop the data processing chain to detect contrast signals in the left-ventricular wall with contrast-enhanced high-frame rate echocardiography. Determine whether this…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter of this study is the myocardial perfusion deficit between
cardiac segments and/or between the epicardial and the endocardial border,
directly after percutaneous coronary intervention, as determined with
high-frame rate contrast echocardiography. We expect, based on many studies of
post-PCI measurements (e.g., scar tissue on MRI scans; post-mortem histology;
preclinical animal testing) that there is local variation in perfusion both
between segments, as well as trans-mural.
Secondary outcome
• Establish expectation of feasibility in clinical practice in / nearby the
Cath lab, and in the outpatient clinic.
• Develop a comparative framework with current standard protocols for perfusion
imaging (TIMI score, conventional contrast-enhanced echography)
• To explore the added value of high frame-rate echocardiography in patients
that have underwent a PCI.
• Assess the blood flow in the left-ventricular cavity nearby the wall
Background summary
Yearly in the EU, about 3 million patients with a myocardial infarction (MI;
i.e. *heart attack*) receive a minimally-invasive intervention (opening the
obstructed coronary artery with a balloon on a catheter and usually placing a
stent) followed by pharmaceutical treatment. Even after successful
re-canalisation of coronary arteries by catheter interventions (percutaneous
coronary intervention, PCI) in the Cath Lab, a substantial (~30%) part of
hearts still show local perfusion deficits in the culprit region. The exact
origin is unknown and may be diverse, hence follow-up treatment is not
successful. We aim to develop new ultrasound contrast-enhanced perfusion
imaging systems to show perfusion deficits in real time in the Cath Lab, such
that candidate follow-up treatments can be tested immediately after
re-canalisation. This current protocol presents the first three stages of
testing the imaging system in patients, yet (just) outside of the Cath Lab.
Study objective
The objective of this study is three-fold:
1) Assess measurement settings and develop the data processing chain to detect
contrast signals in the left-ventricular wall with contrast-enhanced high-frame
rate echocardiography. Determine whether this potentially shows perfusions
deficits between cardiac segments, and whether perfusion differences are
visible in a 3-6 month PCI follow-up.
2) Establish the feasibility of measuring myocardial perfusion with high-frame
rate echocardiography in patients that have underwent a PCI or are hospitalized
for cardiac disease.
3) Assess the blood flow in the left-ventricular cavity near the wall.
Study design
This will be an observational cohort study divided into four stages. The first
two stages are intended for fine-tuning the acquisition and post-processing
techniques, while the third and fourth stage will investigate actual
discriminative power for cardiac perfusion deficiency imaging. The study will
take place within the Cardiology department of Erasmus MC. Patients will be
examined first with conventional non-contrast AND contrast-enhanced echography,
following their respective regular clinical diagnostic protocols to provide the
diagnostic value for the treating physician. For these contrast-enhanced
echography exams, they will receive a canula (intravenous line) in their
forearm to administer the ultrasound contrast agent. That clinical exam also
provides part of the reference data for the high frame rate technique.
Subsequently, we will use our high frame rate imaging protocol and equipment to
capture the data, analyse the data, and compare the outcome to the reference
data (symptoms, echocardiography, contrast-CT if available from routine care,
intervention data, disease history).
Study burden and risks
The burden of the study procedures consists of extension of the
echocardiographic study which the patient undergoes during the regular visit to
the echocardiography clinic at Erasmus MC (stage 1 and 4B), performing an
echocardiographic exam in the hospital during admission (stage 2), during open
heart surgery (stage 3) or on the medium care unit after percutaneous coronary
intervention in the Cath Lab (stage 4A). Patients will be invited to
participate and with permission of the patient clinical data from the clinical
interview and physical examination may be retrieved from the medical files. The
study is an observational study, physical and physiological discomfort for the
patients is very limited. The ultrasound contrast agent is safe and registered
for the use during echocardiography. There is a small risk of an allergic
reaction after administration of ultrasound contrast agent (0.01%). During all
examinations a medical doctor will be present to react immediately in case of
an allergic reaction. Additional blood tests will not be required. The risks
associated with participation can be considered negligible and the burden can
be considered minimal.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
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:
• Aged >= 18 years.
• Capable of understanding and signing informed consent.
• Stage 1:
o scheduled for conventional contrast-enhanced echocardiography
• Stage 2:
o Admitted to the Erasmus MC Cardiology ward for an elective cardiac procedure
• Stage 3:
o Admitted to the Erasmus MC Cardiology ward
o Planned for cardiac surgery
• Stage 4A:
o underwent PCI in the past hour;
o is recovering in the medium-care unit;
o is physiologically stable and awake;
o suffered a single-vessel ST-elevated myocardial infarction
o still carries an intravenous line;
o oral explicit approval by the treating intervention cardiologist to perform a
contrast-enhanced echographic study in the medium-care unit for this patient.
• Stage 4B:
o Was included in stage 4A, at most 6 months before (range: 3 - 6 months)
o Is physiologically stable
o Has had no serious adverse events or other cardiac complaints/STEMIs in the
mean time
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Patients living abroad or who are not Dutch speaking;
• Any contra-indication for contrast media Sonovue (Bracco International bv,
Amsterdam), or Luminity (Dutch supplier: LamePro bv, Breda);
• Patients with inability to obtain adequate echocardiographic examination;
• Pregnant and/or lactating women
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 | NL77620.078.22 |