The aim of this study is to validate the new invasive method of quantifying MR with the gold standard: [15O]H2O PET perfusion imaging
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between [15O]H2O PET perfusion imaging MR and invasive MR.
Secondary outcome
To investigate whether saline infusion and adenosine infusion produce coronary
microvascular vasodilation equally. We expect this to be true, and if this is
the case, adenosine administration is no longer needed for this measurement.
Background summary
In patients with coronary artery disease, there is a mismatch between visual
interpretation of the coronary angiogram and the presence of myocardial
ischemia. Absolute quantification of coronary blood flow (CBF) in millilitres
per minute and microcirculatory resistance (MR) is heralded as the holy grail
of physiological assessment of the coronary circulation. At present, only
myocardial perfusion [15O]H2O PET is able to quantify volumetric CBF and MR,
and is the gold standard for assessment of CBF. Widespread application is
prohibited however, due to poor availability of [15O]H2O PET. New insights and
developments have led to a simple invasive measurement to quantify CBF and MR.
Study objective
The aim of this study is to validate the new invasive method of quantifying MR
with the gold standard: [15O]H2O PET perfusion imaging
Study design
Prospective cohort study
Study burden and risks
The study is deemed to have mild risks for the patient. The risk of this study
consists of the occurence of AV-nodal block during infusion of cold saline.
Previous studies however, have shown that conduction disturbances do not occur
unless infusion temperature exceeds the minimum 33 degrees Celsius. Thus, it is
of critical importance that the saline infusion is not adjusted to rapidly. As
long as interventional cardiologist are aware of this, AV-conduction
disturbances will not pose a threat. If somehow, AV-block does occur, this
condition can be easily treated by ceasing saline infusion with or without
administration of atropine. Finally, study participation increases patient
radiation exposure by 3,772 mSv. The PET-scan and absolute flow measurements
results in an additional 3,1 mSv and 0,672 mSv, respectively. The results of
this study however, are tremendously important in order to understand and
diagnose microvascular angina in the future.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Stable 1 or 2 vessel ischemic heart disease with at least 1 unobstructed reference coronary artery, where at least 1 coronary artery with a stenosis and 1 reference coronary artery both subtend 10% or more of the left ventricle as estimated by coronary computed tomography angiography (CCTA)
* Age at least 18 years
* Presence of a segment of at least 3 cm without major side branches proximal to the stenosis and in the reference coronary artery a segment with a length of at least 3 cm without major side branches has to be present
Exclusion criteria
* Pregnancy
* Uncorrected severe valvular heart disease
* Non-ischemic cardiomyopathy with left ventricular ejection fraction <35%
* Previous or active myocardial infarction in either the territory with stenosis or reference territory
* Previous coronary artery bypass grafting
* Presence of chronic total occlusion in any coronary artery
* Absolute contra-indications to intravenous adenosine administration (Chronic Obstructive Pulmonary Disease Gold class IV, systemic hypotension (Mean blood pressure <70 mmHg), third degree AV nodal conduction disturbances).
* Estimated Glomular Filtration Rate < 30 ml/min/1,73m²
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 | NL59594.029.16 |