Coronary Artery DiseaseGlaMoRouSNCT02857790
Glasgow MRI and Rotablation Study
An observational study of Coronary Artery Disease, run by NHS National Waiting Times Centre Board.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Near consecutive eligible patients undergoing elective PCI with rotablation.
Who may be able to join
- Stable angina
- Indication for PCI with rotablation
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Keywords
- Rotablation, High speed rotational atherectomy, Type IV myocardial infarction, Cardiac magnetic resonance imaging, CMR, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in circumferential myocardial strain
Measured: 1 week and 6 months post-rotablation
Secondary outcomes (7)
Incidence of CMR detected de novo late gadolinium enhancement
Measured: 1 week and 6 months post-rotablation
Incidence of type IV myocardial infarction
Measured: 6-12 hours post-rotablation
Change in ischaemic burden
Measured: 1 week and 6 months post-rotablation
Change in left ventricular ejection fraction (LVEF)
Measured: 1 week and 6 months post-rotablation
Change in left ventricular (LV) volumes
Measured: 1 week and 6 months post-rotablation
Index of Microcirculatory Resistance (IMR)
Measured: Intra-procedural baseline, intra-procedural post-rotablation, and intra-procedural post-stenting
Minimum Stent Area (MSA)
Measured: Intra-procedural post-rotablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startMar 2012
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS National Waiting Times Centre Board
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Cardiovascular Research Foundation, New York, Medical Research Scotland, Chief Scientist Office of the Scottish Government, Scottish Funding Council, Engineering and Physical Sciences Research Council (EPSRC)
- Responsible party
- Principal investigator, Margaret McEntegart, NHS National Waiting Times Centre Board
- Investigators
- Margaret McEntegart, Principal investigator, Golden Jubilee National HospitalColin Berry, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857790
- Sponsor's protocol ID
- 11/CARD/18
- Acronym
- GlaMoRouS
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Before and After Coronary Angioplasty With Rotational Atherectomy
- ClinicalTrials.gov ID
- NCT02857790
- Acronym / sponsor ID
- GlaMoRouS / 11/CARD/18
- Conditions
- Coronary Artery Disease
- Keywords
- Rotablation, High speed rotational atherectomy, Type IV myocardial infarction, Cardiac magnetic resonance imaging, CMR, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- NHS National Waiting Times Centre BoardUniversity, hospital or other
- Collaborators
- University of Glasgow, Cardiovascular Research Foundation, New York, Medical Research Scotland, Chief Scientist Office of the Scottish Government, Scottish Funding Council, Engineering and Physical Sciences Research Council (EPSRC)
- Study start
- Mar 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Near consecutive eligible patients undergoing elective PCI with rotablation.
Key inclusion criteria (2 listed)
- Stable angina
- Indication for PCI with rotablation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in circumferential myocardial strain
Time frame: 1 week and 6 months post-rotablation
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret McEntegart principal investigator
Golden Jubilee National Hospital
Colin Berry principal investigator
University of Glasgow
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by NHS National Waiting Times Centre Board.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circumferential myocardial strain (time frame: 1 week and 6 months post-rotablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.