- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01368237
Dynamic Myocardial Perfusion Imaging by 320 Multidetector Computed Tomography
June 21, 2018 updated by: University of Edinburgh
Recent advances in technology have resulted in the development of scanners that can image the heart blood vessels within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters.
Further advances in technology allow the visualisation of both the blood vessels and the supply of blood to the heart muscle.
Here we propose to assess the latest and most powerful computed tomography scanner and compare it to magnetic resonance and conventional coronary angiography.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Scotland
-
Edinburgh, Scotland, United Kingdom
- Royal Infirmary of Edinburgh
-
-
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
Patients awaiting invasive coronary angiography
Description
Inclusion Criteria:
- referred for invasive coronary angiography because of suspected coronary heart disease
Exclusion Criteria:
- inability or unwillingness to undergo computed tomography or magnetic resonance imaging
- renal failure (serum creatinine >200 micromol/L or estimated glomerular filtration rate <30 mL/min)
- hepatic failure
- allergy to iodinated contrast or gadolinium
- pregnancy
- contraindication to adenosine infusion
- inability to give informed consent
- inability to perform fractional flow reserve during invasive coronary angiography
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Patients awaiting invasive coronary angiography
|
Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and imaging of myocardial perfusion, function and viability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software
Time Frame: 1 month
|
The primary outcome measure is to establish whether 320-multidetector computed tomography can identify myocardial perfusion defects as compared to the gold standards of 3Tesla magnetic resonance imaging and fractional flow reserve measured during invasive coronary angiography.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of regional wall motion abnormalities qualitatively by trained observers
Time Frame: 1 month
|
Our secondary outcome measures are to assess the performance of 320-multidetector computed tomography in the detection of regional wall motion abnormalities in comparison to those obtained with 3Tesla cardiac magnetic resonance imaging.
|
1 month
|
Identification of infarction qualitatively by trained observers
Time Frame: 1 month
|
Our secondary outcome measures are to assess the performance of 320-multidetector computed tomography in the detection of infarction in comparison to those obtained with 3Tesla cardiac magnetic resonance imaging.
|
1 month
|
Identification of regional wall motion abnormalities quantitatively by computer software
Time Frame: 1 month
|
Our secondary outcome measures are to assess the performance of 320-multidetector computed tomography in the detection of regional wall motion abnormalities in comparison to those obtained with 3Tesla cardiac magnetic resonance imaging.
|
1 month
|
Identification of infarction qualitatively by computer software
Time Frame: 1 month
|
Our secondary outcome measures are to assess the performance of 320-multidetector computed tomography in the detection of infarction in comparison to those obtained with 3Tesla cardiac magnetic resonance imaging.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
May 1, 2006
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
June 6, 2011
First Submitted That Met QC Criteria
June 6, 2011
First Posted (Estimate)
June 7, 2011
Study Record Updates
Last Update Posted (Actual)
June 25, 2018
Last Update Submitted That Met QC Criteria
June 21, 2018
Last Verified
October 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210/R/CAR/11
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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