Glasgow MRI and Rotablation Study (GlaMoRouS)

August 4, 2016 updated by: Margaret McEntegart, NHS National Waiting Times Centre Board

MRI Before and After Coronary Angioplasty With Rotational Atherectomy

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

58

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Near consecutive eligible patients undergoing elective PCI with rotablation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in circumferential myocardial strain
Time Frame: 1 week and 6 months post-rotablation
1 week and 6 months post-rotablation

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of CMR detected de novo late gadolinium enhancement
Time Frame: 1 week and 6 months post-rotablation
1 week and 6 months post-rotablation
Incidence of type IV myocardial infarction
Time Frame: 6-12 hours post-rotablation
6-12 hours post-rotablation
Change in ischaemic burden
Time Frame: 1 week and 6 months post-rotablation
1 week and 6 months post-rotablation
Change in left ventricular ejection fraction (LVEF)
Time Frame: 1 week and 6 months post-rotablation
1 week and 6 months post-rotablation
Change in left ventricular (LV) volumes
Time Frame: 1 week and 6 months post-rotablation
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
Intra-procedural baseline, intra-procedural post-rotablation, and intra-procedural post-stenting
Minimum Stent Area (MSA)
Time Frame: Intra-procedural post-rotablation
Intra-procedural post-rotablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS National Waiting Times Centre Board

Collaborators

University of Glasgow
Cardiovascular Research Foundation, New York
Chief Scientist Office of the Scottish Government
Medical Research Scotland
Scottish Funding Council
Engineering and Physical Sciences Research Council (EPSRC)

Investigators

  • Principal Investigator: Margaret McEntegart, Golden Jubilee National Hospital
  • Principal Investigator: Colin Berry, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/CARD/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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