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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01368237
Other study ID # 210/R/CAR/11
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2006
Est. completion date January 1, 2017

Study information

Verified date October 2014
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date January 1, 2017
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Radiation:
Computed tomography scan
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.

Locations

Country Name City State
United Kingdom Royal Infirmary of Edinburgh Edinburgh Scotland

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software 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 Identification of regional wall motion abnormalities qualitatively by trained observers 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
Secondary Identification of infarction qualitatively by trained observers 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
Secondary Identification of regional wall motion abnormalities quantitatively by computer software 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
Secondary Identification of infarction qualitatively by computer software 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
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