Glasgow MRI and Rotablation Study

NCT02857790 | Completed

• 1 other identifier: 11/CARD/18
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

Rotablation; High speed rotational atherectomy; Type IV myocardial infarction; Cardiac magnetic resonance imaging; CMR; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Change in circumferential myocardial strain

  1 week and 6 months post-rotablation

Secondary Outcomes (7)

• Incidence of CMR detected de novo late gadolinium enhancement

  1 week and 6 months post-rotablation

• Incidence of type IV myocardial infarction

  6-12 hours post-rotablation

• Change in ischaemic burden

  1 week and 6 months post-rotablation

• Change in left ventricular ejection fraction (LVEF)

  1 week and 6 months post-rotablation

• Change in left ventricular (LV) volumes

  1 week and 6 months post-rotablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Near consecutive eligible patients undergoing elective PCI with rotablation.

You may qualify if:

• Stable angina
• Indication for PCI with rotablation

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS National Waiting Times Centre Board: lead
• University of Glasgow: collaborator
• Cardiovascular Research Foundation, New York: collaborator
• Medical Research Scotland: collaborator
• Chief Scientist Office of the Scottish Government: collaborator
• Scottish Funding Council: collaborator
• Engineering and Physical Sciences Research Council (EPSRC): collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Margaret McEntegart

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

• Colin Berry

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: August 5, 2016
• Study Start: March 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share