To assess the diagnostic value of adenosine myocardial stress perfusion MR in the functional evaluation of patients undergoing a standard PCI with FFR-measurements for single or two vessel disease.
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The presence of visual or measurable reversible perfusiondefects
Secondary outcome
Agreement between adenosine perfusion MR with CAG and FFR-measurements.
qualitative versus quantitative assessment of myocardial perfusion. Quantifying
the effect of PCI on left ventricular function. Feasibility of TSENSE sequence
in an adenosine perfusion MR protocol
Background summary
The increase in flow through the coronary arteries relies mostly on
vasodilatation. Compensatory vasodilatation distal to a stenosis is able to
maintain flow during rest, but during stress (or pharmacologically induced
stress) conditions this capacity is exceeded. Adenosine induces vasodilatation
of the coronary arteries. Stenotic coronary arteries bear the capacity to
further dilate, which creates a relative area of hypoperfusion in the supplied
myocardium compared to segments supplied by normal coronary arteries.
A persisting perfusion abnormality after coronary intervention is associated
with a higher risk of significant restenosis. Therefore a non-invasive imaging
technique that can accurately assess the functional effect of percutaneous
coronary intervention would be ideal.
Study objective
To assess the diagnostic value of adenosine myocardial stress perfusion MR in
the functional evaluation of patients undergoing a standard PCI with
FFR-measurements for single or two vessel disease.
Study design
Prospective, exploratory study in patients with single or two vessel disease,
who are planned for PCI on the basis of a CAG. an adenosine perfusion MR will
be performed on the day of admittance and one day after the PCI.
Study burden and risks
Untill present day no hazardous effect of MRI are documented. MRI is
contra-indicated in patients with non-MR compatible implants and claustrofobia.
The contrast agent used with MR examinations, Gadoterate meglumine is
considered very safe, and has been used in clinical practice for many years. In
some cases nausea (1-2%) or hives(<1%) can occur. In very rare cases an
anaphylactoid reaction can occur.
Adenosine is well tolerated and is widely used in a clinical setting for
visualisation of myocardial perfusion in nuclear imaging, as well as in MRI.
Contra-indications for adenosine are documented and described in the exclusion
criteria. Severe side-effect are rare,and consist of AV-block, ventricular
fibrillation, bradycardia, hypotension, bronchospasm and ST-depression.
Side-effects expressed in order of incidence are: flushing (37-44%), chest
discomfort (35-40%), dyspnoe (28-35%), headache (14-18%), anginal discomfort of
neck, throat or jaw (12-15%), gastro-intestinal discomfort (13-15%),
lightheadedness (9-12%), ST-segment-depression (3%), first-degree AV-block
(3%), second-degree AV-block (3%), third-degree AV-block (0.8%), hypotension
(2%), arrhythmia (1%). Adenosine is contra-indicated in second or third degree
AV block, sick-sinus syndrome, asthma and other obstructive pulmonary disease,
severe hypotension, unstable angina, heart failure, prolonged QT-interval and
pregnancy.
P.O. Box 30.001
9700 RB Groningen
Nederland
P.O. Box 30.001
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
single or two-vessel coronary artery disease
Exclusion criteria
COPD
asthma
persantin usage
Non-MR compatible implants
claustrophobia
second and third degree heart block
Sick-sinus syndrome
severe hypotension
heart failure
prolonged QT-time
Pregnancy
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 | NL12386.042.06 |