Glasgow MRI and Rotablation Study

NCT02857790 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2016-08-05

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER
  • Cardiovascular Research Foundation, New York

    collaborator OTHER
  • Medical Research Scotland

    collaborator UNKNOWN
  • Chief Scientist Office of the Scottish Government

    collaborator OTHER_GOV
  • Scottish Funding Council

    collaborator UNKNOWN
  • Engineering and Physical Sciences Research Council (EPSRC)

    collaborator UNKNOWN
  • NHS National Waiting Times Centre Board

    lead OTHER

Principal Investigators

  • Margaret McEntegart · Golden Jubilee National Hospital

  • Colin Berry · University of Glasgow

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2016-01-31
Completion
2016-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02857790 on ClinicalTrials.gov