NCT02857790|Completed
Glasgow MRI and Rotablation Study
GlaMoRouS
MRI Before and After Coronary Angioplasty With Rotational Atherectomy
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GlaMoRouS
MRI Before and After Coronary Angioplasty With Rotational Atherectomy
Sponsor study identifier
observational
58
0 countries
N/A
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
June 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 2016
Actual (reported)June 2016
Actual (reported)July 20, 2016
Actual (reported)August 5, 2016
Actual (reported)Change in circumferential myocardial strain
1 week and 6 months post-rotablation
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
Near consecutive eligible patients undergoing elective PCI with rotablation.
Margaret McEntegart
Golden Jubilee National Hospital
Colin Berry
University of Glasgow
58 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2016
First Posted
August 5, 2016
Study Start
March 2012
Date type not reportedThis date has not been verified as actual or estimated.
Knowledge-based Iterative Model Reconstruction at Low-kilovoltage (kV) Cardiac Computed Tomography (CT)
Contact the study team to confirm eligibility.
Primary Completion
January 2016
Actual (reported)Study Completion
June 2016
Actual (reported)Last Updated
August 5, 2016
Record last verified: 2016-08
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Source: ClinicalTrials.gov.
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