An observational study in Coronary Artery Disease, sponsored by NHS National Waiting Times Centre Board. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-05.
Sponsored by NHS National Waiting Times Centre Board · Observational
Percutaneous coronary intervention (PCI) with adjunctive high speed rotational atherectomy (HSRA) is commonly used to treat complex and calcified coronary artery stenoses. Theoretically, HSRA may have deleterious effects on the coronary microcirculation and result in peri-procedural myocardial infarction (Type 4a MI).
This study is assessing the effects of HSRA PCI using serial multi-parametric stress perfusion cardiac magnetic resonance imaging (CMR) (1.5 Tesla MAGNETOM Avanto, Siemens Healthcare). The study will prospectively enrol up to 75 patients (minimum completed cohort of 50 patients) undergoing elective HSRA PCI and performing multi-parametric CMR at 3 time-points: before HSRA, 1 week post-HSRA, and 6 months post-HSRA. Myocardial perfusion will be assessed using pharmacological stress with intravenous adenosine (140 micrograms/kg/min) at each time point. High-sensitivity cardiac troponin (hsTn) and ECGs will be performed post-HSRA.
High Speed Rotational atherectomy (HSRA) is a technique used during angioplasty in the treatment of calcified coronary arteries. Rotablation debulks resistant calcium in the coronary artery plaque thus facilitating stent deployment and expansion. The atherectomy technique involves a rotating diamond-tipped burr which breaks down the calcium into small particles which are washed forward by the blood flow into the smaller coronary branches supplying the heart muscle. The dispersed calcium particles may block these smaller blood vessels, interrupting blood flow to an extent that may result in heart muscle damage. When this injury becomes detectable clinically, with symptoms, ECG changes and increased troponin, an iatrogenic type IV myocardial infarction (MI) is diagnosed.
Cardiac magnetic resonance imaging (CMR) is the gold standard method for imaging the heart providing detailed information on cardiac function and muscle injury.
This is a prospective cohort observational study of 60 patients undergoing coronary angioplasty with rotational atherectomy.
The aim of the study is to investigate myocardial injury revealed by paired CMR scans before and after rotational atherectomy.
The hypothesis is that following rotational atherectomy, displacement of calcified particles cause microvascular obstruction leading to reduced perfusion. Since myocardial perfusion and pump function are linked, as myocardial perfusion is reduced after atherectomy, so myocardial contractility (i.e. strain) will reduce. In a second analysis, computer modelling will be used to integrate the different types of CMR information to better understand the spatial, temporal and pathological evolution of myocardial infarction (www.softmech.org). The further hypothesis is that despite CMR detectable infarction the incidence of clinical type IV MI will be low.
CMR scans will be performed 1 week before, 1 week and 6 months post rotablation. Cardiac troponin and ECGs will be performed post rotablation to determine the incidence of type IV MI.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 58 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →NHS National Waiting Times Centre Board is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Near consecutive eligible patients undergoing elective PCI with rotablation.
Exclusion Criteria:
Change in circumferential myocardial strain
Time frame: 1 week and 6 months post-rotablation
Incidence of CMR detected de novo late gadolinium enhancement
Time frame: 1 week and 6 months post-rotablation
Incidence of type IV myocardial infarction
Time frame: 6-12 hours post-rotablation
Change in ischaemic burden
Time frame: 1 week and 6 months post-rotablation
Change in left ventricular ejection fraction (LVEF)
Time frame: 1 week and 6 months post-rotablation
Change in left ventricular (LV) volumes
Time frame: 1 week and 6 months post-rotablation
Index of Microcirculatory Resistance (IMR)
Time frame: Intra-procedural baseline, intra-procedural post-rotablation, and intra-procedural post-stenting
Minimum Stent Area (MSA)
Time frame: Intra-procedural post-rotablation
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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NHS National Waiting Times Centre Board