Glasgow MRI and Rotablation Study

NCT ID: NCT02857790

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2016-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Glasgow

OTHER

Sponsor Role: collaborator

Cardiovascular Research Foundation, New York

OTHER

Sponsor Role: collaborator

Medical Research Scotland

UNKNOWN

Sponsor Role: collaborator

Chief Scientist Office of the Scottish Government

OTHER_GOV

Sponsor Role: collaborator

Scottish Funding Council

UNKNOWN

Sponsor Role: collaborator

Engineering and Physical Sciences Research Council (EPSRC)

UNKNOWN

Sponsor Role: collaborator

NHS National Waiting Times Centre Board

OTHER

Sponsor Role: lead

Responsible Party

Margaret McEntegart

Consultant Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret McEntegart

Role: PRINCIPAL_INVESTIGATOR

Golden Jubilee National Hospital

Colin Berry

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Other Identifiers

11/CARD/18

Identifier Type: -

Identifier Source: org_study_id