Coronary Heart Disease Clinical Trial
Official title:
Dynamic Myocardial Perfusion Imaging by 320 Multidetector Computed Tomography
| 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 |
| Verified date | October 2014 |
| Source | University of Edinburgh |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Scotland |
| Lead Sponsor | Collaborator |
|---|---|
| University of Edinburgh | NHS Lothian |
United Kingdom,
| 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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