Coronary Artery DiseaseNCT00921440
Computed Tomography Coronary Angiography (CTCA) and Coronary Flow in Stenosis Analysis
An observational study of Coronary Artery Disease, run by University of Cologne.
Trial summary
The investigators' rationale was to evaluate whether a 64-slice CT scanner allows accurate measurement of computed tomographic changes in coronary artery flow profiles and whether CT flow measurements are suitable for classifying the significance and hemodynamic relevance of a stenosis and thereby supplement as a… Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2007to Jul 2008
- 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 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people with suspected or known coronary artery disease (CAD)
Who may be able to join
- Clinically known or presumed CAD
- Age > 50 years
- Hospitalization for invasive coronary angiography
- Sinus rhythm
- Written informed consent by the patient to participate in the study after comprehensive presentation of the facts
Who cannot join
- Age <= 50 years
- Contraindications to contrast media administration (medical history of iodine allergy, nephropathy, latent or manifest hyperthyroidism)
- Arrhythmias
- Dyspnea at rest, acute unstable angina pectoris, acute myocardial infarction
- Pregnancy
- Implanted pacemaker
- Unwillingness of patient to consent to the study
About this study
Official title: CT Coronary Angiography: Coronary Flow Quantification Supplements Morphological Stenosis Analysis
The investigators' rationale was to evaluate whether a 64-slice CT scanner allows accurate measurement of computed tomographic changes in coronary artery flow profiles and whether CT flow measurements are suitable for classifying the significance and hemodynamic relevance of a stenosis and thereby supplement as a functional parameter for morphological stenosis analysis.
Read the detailed description
A total of 50 patients prospectively underwent computed tomography coronary angiography (CTCA) in a multidetector CT scanner (Brilliance 64, Philips) ± 1 day before or after invasive coronary angiography (ICA). Immediately thereafter, 2 radiologists reviewed the imaging data to detect any vessel segments with morphology poorly evaluable by CTCA. A locally constant cyclical measurement was acquired in these coronary arteries in breath-hold technique during the passage of a 50ml bolus of contrast media. For analysis, time-density curves of the bolus passage were registered in the coronary artery and the aorta (internal reference), the up-slopes were determined and correlated with each other. The results were compared with the ICA findings.
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery, stenosis
- Medical subject headings
- Coronary Artery Disease, Constriction, Pathologic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2009 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Dept. of Radiology
- Investigators
- Barbara Krug, Prof. Dr., Principal investigator, Dept. of Radiology, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00921440
- Sponsor's protocol ID
- 22462/2 - 2005-070
- Status last verified
- Jun 2009
- First submitted
- 15 Jun 2009
- Last updated
- 16 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Coronary Angiography: Coronary Flow Quantification Supplements Morphological Stenosis Analysis
- ClinicalTrials.gov ID
- NCT00921440
- Acronym / sponsor ID
- 22462/2 - 2005-070
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery, stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Dept. of Radiology
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Jun 2009 (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.
The investigators' rationale was to evaluate whether a 64-slice CT scanner allows accurate measurement of computed tomographic changes in coronary artery flow profiles and whether CT flow measurements are suitable for classifying the significance and hemodynamic relevance of a stenosis and thereby supplement as a functional parameter for morphological stenosis analysis.
Detailed description
A total of 50 patients prospectively underwent computed tomography coronary angiography (CTCA) in a multidetector CT scanner (Brilliance 64, Philips) ± 1 day before or after invasive coronary angiography (ICA). Immediately thereafter, 2 radiologists reviewed the imaging data to detect any vessel segments with morphology poorly evaluable by CTCA. A locally constant cyclical measurement was acquired in these coronary arteries in breath-hold technique during the passage of a 50ml bolus of contrast media. For analysis, time-density curves of the bolus passage were registered in the coronary artery and the aorta (internal reference), the up-slopes were determined and correlated with each other. The results were compared with the ICA findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people with suspected or known coronary artery disease (CAD)
Key inclusion criteria (5 listed)
- Clinically known or presumed CAD
- Age > 50 years
- Hospitalization for invasive coronary angiography
- Sinus rhythm
- Written informed consent by the patient to participate in the study after comprehensive presentation of the facts
Key exclusion criteria (7 listed)
- Age <= 50 years
- Contraindications to contrast media administration (medical history of iodine allergy, nephropathy, latent or manifest hyperthyroidism)
- Arrhythmias
- Dyspnea at rest, acute unstable angina pectoris, acute myocardial infarction
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 16 Jun 2009.
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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.
Barbara Krug, Prof. Dr. principal investigator
Dept. of Radiology, University Hospital of Cologne
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Cologne.
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 5 inclusion and 7 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 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 16 Jun 2009.