Clinical trial NCT02857790: Glasgow MRI and Rotablation Study
Official title: MRI Before and After Coronary Angioplasty With Rotational Atherectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Rotablation
High speed rotational atherectomy
Type IV myocardial infarction
Cardiac magnetic resonance imaging
CMR
Percutaneous Coronary Intervention
Lead sponsor: NHS National Waiting Times Centre Board
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: Cardiovascular Research Foundation, New York
name: Medical Research Scotland
name: Chief Scientist Office of the Scottish Government
name: Scottish Funding Council
name: Engineering and Physical Sciences Research Council (EPSRC)
First posted: 2016-08-05
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Near consecutive eligible patients undergoing elective PCI with rotablation.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Stable angina
* Indication for PCI with rotablation

Exclusion Criteria:

* Other major systemic illness
* Contra-indication to CMR
* Pregnancy
* CKD (eGFR\<30)
* Pre-existing infarct in culprit vessel territory on ECG, echo or baseline CMR
* Chronic total occlusion

Primary outcomes:
measure: Change in circumferential myocardial strain
timeFrame: 1 week and 6 months post-rotablation
Secondary outcomes:
measure: Incidence of CMR detected de novo late gadolinium enhancement
timeFrame: 1 week and 6 months post-rotablation
measure: Incidence of type IV myocardial infarction
timeFrame: 6-12 hours post-rotablation
measure: Change in ischaemic burden
timeFrame: 1 week and 6 months post-rotablation
measure: Change in left ventricular ejection fraction (LVEF)
timeFrame: 1 week and 6 months post-rotablation
measure: Change in left ventricular (LV) volumes
timeFrame: 1 week and 6 months post-rotablation
measure: Index of Microcirculatory Resistance (IMR)
timeFrame: Intra-procedural baseline, intra-procedural post-rotablation, and intra-procedural post-stenting
measure: Minimum Stent Area (MSA)
timeFrame: Intra-procedural post-rotablation
Other outcomes:
Locations:
Study officials:
affiliation: Golden Jubilee National Hospital
name: Margaret McEntegart
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow
name: Colin Berry
role: PRINCIPAL_INVESTIGATOR
References: