The objective of the study is to collect data for offline analysis. The analysis will evaluate the correlation of cDSA derived parameters and intracoronary pressure and flow measures.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation of cDSA-derived parameters and Doppler flow velocity-derived
parameters of microvascular resistance during hyperemic flow and coronary flow
reserve, pre-and post PCI.
Patiënts will receive a PCI of the LAD following standard of care. However,
before the PCI 2 additional angiograms will be acquired, before and after
administration of adenosine. Simultaneously, intracoronary flow and pressure
will be measured with a Combowire positioned in the LAD. Following the PCI the
same will be repeated.
Secondary outcome
Not applicable.
Background summary
Patients with stable angina complaints and suspected coronary artery disease
often have an indication for a coronary angiography (CAG). During CAG the
epicardial coronary arteries are visualized with X-ray by injection of
iodinated contrast agent, thereby allowing assessment of arterial lumen
patency. However, myocardial blood flow is not only regulated by these
epicardial vessels but, for a much larger part, by the function of the coronary
microvascular circulation. Due to limited visibility of these smaller vessels
on CAG the clinical significance of microvascular dysfunction (MVD) has not
been given as much attention as epicardial coronary artery disease. More
recently, it has been shown that MVD does indicate an adverse prognostic effect
in patients with non obstructive epicardial coronary arteries. Furthermore, in
1-14% of patients presenting with an acute coronary syndrome (ACS) the
angiography shows no evidence of obstructive epicardial coronary artery disease
and a subset of these patients might actually suffer from MVD.
MVD is characterized by elevated coronary microvascular resistance. Although
there is no generally accepted gold standard for the assessment of MVD, there
are two invasive coronary physiology measures which represent MVD, respectively
the index of microvascular resistance (IMR) and hyperemic microvascular
resistance (hMR). The general measure for myocardial blood flow is coronary
flow reserve (CFR). All these measures are invasively measured with either flow
or thermodilution wires. They furthermore require the administration of
adenosine to allow the comparison of the baseline situation to a situation
during hyperemia.
Philips has recently developed a non invasive alternative for the assessment of
MVD. The tool converts a digital subtraction angiography (DSA) into a perfusion
image. Parameters derived from this perfusion image, either comparing pre and
post adenosine or comparing potential diseased regions to healthy regions,
might show correlation to invasively derived measures of MVR.
Study objective
The objective of the study is to collect data for offline analysis. The
analysis will evaluate the correlation of cDSA derived parameters and
intracoronary pressure and flow measures.
Study design
The present study encompasses a single-centre observational validation-study to
investigate the diagnostic potential of DSA-derived functional parameters to
detect CMD as defined by conventional invasive measurements. The study will be
funded by an unrestricted research grant supplied by Philips healthcare.
Study burden and risks
The burden of participating in this studies equals the prolongation of the
procedure with 20min. moreover, the patient will be exposed to slightly more
contrast medium and radiation.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Age >18 years.
* Presence of an epicardial stenosis of *50% diameter stenosis in the left
anterior descending (LAD) artery.
* Presence of stable angina (Canadian Cardiovascular Society (CCS) score I-III).
Able to understand and sign the informed consent.
Exclusion criteria
Patients <18 years of age,. +
* Left main involvement requiring revascularization.
* Cardiac arrhythmia.
* Sequential lesions in the LAD
* Extremely tortuous or calcified coronary arteries that impede adequate
physiologic measurements.
* Recent (<6 weeks) myocardial infarction (STEMI or NSTEMI).
* Severe valvular abnormalities.
* Impaired left ventricular (LV) function (ejection fraction <55%).
* LV hypertrophy (>13mm septal wall thickness).
* Unable to undergo percutaneous intervention or receive adenosine (severe
reactive airway disease, severe hypotension or high-grade Atrio-Ventricular
(AV) block in the absence of a pacemaker.
* Signs or history of cardiomyopathy.
* Signs of (peri)myocarditis
* Collateral formation in target vessel.
* CABG to target vessel.
* Renal failure (MDRD calculated eGFR of <30).
* 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 | NL67903.018.18 |