Coronary Heart DiseaseNCT01368237
Dynamic Myocardial Perfusion Imaging by 320 Multidetector Computed Tomography
An observational study of Coronary Heart Disease, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Computed tomography scan
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2006to 1 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients awaiting invasive coronary angiography
Who may be able to join
- referred for invasive coronary angiography because of suspected coronary heart disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Coronary Heart Disease
- Being tested
- Computed tomography scan
- Keywords
- Computed tomography, Myocardial perfusion, Coronary heart disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography scanRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients awaiting invasive coronary angiography Receives: Radiation: Computed tomography scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (4)
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startMay 2006
- Primary completionJun 2014
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
- Investigators
- David E Newby, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368237
- Sponsor's protocol ID
- 210/R/CAR/11
- Status last verified
- Oct 2014
- First submitted
- 6 Jun 2011
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Papanastasiou G, Williams MC, Dweck MR, Alam S, Cooper A, Mirsadraee S, Newby DE, Semple SI. Quantitative assessment of myocardial blood flow in coronary artery disease by cardiovascular magnetic resonance: comparison of Fermi and distributed parameter modeling against invasive methods. J Cardiovasc Magn Reson. 2016 Sep 13;18(1):57. doi: 10.1186/s12968-016-0270-1.
PubMed 27624746
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Myocardial Perfusion Imaging by 320 Multidetector Computed Tomography
- ClinicalTrials.gov ID
- NCT01368237
- Acronym / sponsor ID
- 210/R/CAR/11
- Conditions
- Coronary Heart Disease
- Keywords
- Computed tomography, Myocardial perfusion, Coronary heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- May 2006
- Primary completion
- Jun 2014 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Radiation: Computed tomography scanPatients awaiting invasive coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients awaiting invasive coronary angiography
Key inclusion criteria (1 listed)
- referred for invasive coronary angiography because of suspected coronary heart disease
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography scanComputed 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. | Radiation | Patients |
Primary outcome
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.
4 secondary outcomes
Identification of regional wall motion abnormalities qualitatively by trained observers
Time frame: 1 month
Identification of infarction qualitatively by trained observers
Time frame: 1 month
Identification of regional wall motion abnormalities quantitatively by computer software
Time frame: 1 month
Identification of infarction qualitatively by computer software
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Derived from this study: PubMed 27624746Papanastasiou G, Williams MC, Dweck MR, Alam S, Cooper A, Mirsadraee S, Newby DE, Semple SI. Quantitative assessment of myocardial blood flow in coronary artery disease by cardiovascular magnetic resonance: comparison of Fermi and distributed parameter modeling against invasive methods. J Cardiovasc Magn Reson. 2016 Sep 13;18(1):57. doi: 10.1186/s12968-016-0270-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David E Newby principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01368237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.