Coronary Artery DiseasePhase 43-DCANCT00447148
Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison
A Phase 4 study testing 3-dimensional coronary angiography in people with Coronary Artery Disease, run by Antwerp Cardiovascular Institute Middelheim at 1 site in Belgium.
Trial summary
Aim of this study is to evaluate whether the length of coronary segments, assessed by an experienced operator, using the "optimal view" of standard 2-dimensional coronary angiography, is over/underestimated with respect to the one evaluated automatically with the help of a 3-dimensional coronary reconstruction model. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 3-dimensional coronary angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2006to Jul 2007
- Phase
- Phase 4
- 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
Who may be able to join
- Clinical
- Age > 18 years.
- Ability to give informed consent.
- Clinical evidence of coronary artery disease:
- recent (< 72 hours) acute myocardial infarction,
- stable angina with documented positive stress test,
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- unstable angina with documented ischemia (positive ECG or troponin test or documented positive stress test).
- Angiographic
- Eligibility for PCI in at least one de-novo stenosis in a native coronary artery, after the index angiogram.
- Planned PCI according to a previous coronary angiogram.
Who cannot join
- Clinical
- Pregnancy.
- Chronic or acute renal failure (serum creatinine > 1.8 mg/dL or hemodialysis).
- Urgent procedure (a procedure carried out before the next referring day, for example for acute myocardial infarction, unstable angina refractory to medical therapy or cardiogenic shock).
- Contraindications or known hypersensitivity to contrast media.
- Enrollment in another study protocol.
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- Angiographic
- Significant left main coronary artery disease.
- PCI for a total occlusion of a major coronary vessel (LAD, LCX or RCA).
- Extensive thrombotic burden in a coronary lesion (thrombus grade 3/4).
- TIMI flow <3 distal to the lesion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"
Aim of this study is to evaluate whether the length of coronary segments, assessed by an experienced operator, using the "optimal view" of standard 2-dimensional coronary angiography, is over/underestimated with respect to the one evaluated automatically with the help of a 3-dimensional coronary reconstruction model. Moreover, both techniques are compared with an "in-vivo" surrogate of the real length of the coronary segment under evaluation, i.e. an intra-coronary marker guide-wire, which is a wire with markers placed at fixed and known distance along its length in its distal (intra-coronary) part. Two hypotheses are tested: (1) the length of a coronary segment evaluated with a standard 2-dimensional "optimal view" over/underestimates the length assessed by a 3-dimensional coronary model that automatically detects the least foreshortened length of the segment under evaluation, and (2) the 3-dimensional model approximates more closely than standard 2-dimensional angiography, the real length of the segment detected by the marker guide-wire.
Read the detailed description
The potential to improve the accuracy of the assessment of the coronary tree by means of 3-D modeling reconstruction may lead to an evaluation of the coronary artery anatomy that approximates more correctly the real anatomy, thus subsequently leading to a more tailored diagnosis and therapy for the patients with ischemic heart disease.
Aim of the current study is to assess whether a 3-D model of the coronary tree offers a less foreshortened and less operator-dependent evaluation of the length of the coronary arteries with respect to standard coronary angiography. Furthermore, for the first time "in-vivo", a comparison with the "real" length of the vessel will be performed using as "gold standard" an intra-coronary guide-wire with radiopaque markers at fixed and known distance one from the other along its distal part.
- Conditions
- Coronary Artery Disease
- Being tested
- 3-dimensional coronary angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-dimensional coronary angiographyProcedure or surgery
Also called coronary angiography
3-dimensional coronary angiography
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Paired comparison of 2 angiographic techniques Receives: Procedure: 3-dimensional coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
standard coronary angiography over/underestimates the length of the coronary segment evaluated.
Measured: peri-procedural
Secondary outcomes (4)
The length of the segments, evaluated with standard and 3-D angiography, will be compared with the length of the segment measured with the marker guide-wire.
Each group of the same vessel(LAD, RCA, CX) will be evaluated separately.
All the QCA results of standard angiography will be compared with those of 3-D angiography, in particular in the segments where the lesion is.
The percentage of vessel foreshortening of the standard angiography operator-selected "working view" will be compared to the least foreshortened view automatically selected with the 3-D angiography reconstruction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startOct 2006
- Study completionJul 2007
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antwerp Cardiovascular Institute Middelheim
- Sponsor type
- University, hospital or other
- Investigators
- Pierfrancesco Agostoni, MD, Principal investigator, Antwerp Cardiovascular Institute MiddelheimStefan Verheye, MD, PhD, Study chair, Antwerp Cardiovascular Institute MiddelheimGlenn Van Langenhove, MD, PhD, Study director, Antwerp Cardiovascular Institute Middelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447148
- Sponsor's protocol ID
- ACIM 2006-001
- Acronym
- 3-DCA
- Status last verified
- Oct 2007
- First submitted
- 13 Mar 2007
- Last updated
- 31 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard vs. 3-Dimensional Coronary Angiography: a Paired Comparison Using Intra-Coronary Marker Wires as Matched-Comparison "Gold Standard"
- ClinicalTrials.gov ID
- NCT00447148
- Acronym / sponsor ID
- 3-DCA / ACIM 2006-001
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Antwerp Cardiovascular Institute MiddelheimUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 14 Mar 2007 (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.
Aim of this study is to evaluate whether the length of coronary segments, assessed by an experienced operator, using the "optimal view" of standard 2-dimensional coronary angiography, is over/underestimated with respect to the one evaluated automatically with the help of a 3-dimensional coronary reconstruction model. Moreover, both techniques are compared with an "in-vivo" surrogate of the real length of the coronary segment under evaluation, i.e. an intra-coronary marker guide-wire, which is a wire with markers placed at fixed and known distance along its length in its distal (intra-coronary) part. Two hypotheses are tested: (1) the length of a coronary segment evaluated with a standard 2-dimensional "optimal view" over/underestimates the length assessed by a 3-dimensional coronary model that automatically detects the least foreshortened length of the segment under evaluation, and (2) the 3-dimensional model approximates more closely than standard 2-dimensional angiography, the real length of the segment detected by the marker guide-wire.
Detailed description
The potential to improve the accuracy of the assessment of the coronary tree by means of 3-D modeling reconstruction may lead to an evaluation of the coronary artery anatomy that approximates more correctly the real anatomy, thus subsequently leading to a more tailored diagnosis and therapy for the patients with ischemic heart disease.
Aim of the current study is to assess whether a 3-D model of the coronary tree offers a less foreshortened and less operator-dependent evaluation of the length of the coronary arteries with respect to standard coronary angiography. Furthermore, for the first time "in-vivo", a comparison with the "real" length of the vessel will be performed using as "gold standard" an intra-coronary guide-wire with radiopaque markers at fixed and known distance one from the other along its distal part.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Procedure: 3-dimensional coronary angiographyPaired comparison of 2 angiographic techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical
- Age > 18 years.
- Ability to give informed consent.
- Clinical evidence of coronary artery disease:
- Angiographic
Key exclusion criteria (11 listed)
- Clinical
- Pregnancy.
- Chronic or acute renal failure (serum creatinine > 1.8 mg/dL or hemodialysis).
- Urgent procedure (a procedure carried out before the next referring day, for example for acute myocardial infarction, unstable angina refractory to medical therapy or cardiogenic shock).
- Contraindications or known hypersensitivity to contrast media.
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 |
|---|---|---|
| 3-dimensional coronary angiographyAlso: coronary angiography3-dimensional coronary angiography | Procedure or surgery | 1 |
Primary outcome
standard coronary angiography over/underestimates the length of the coronary segment evaluated.
Time frame: peri-procedural
4 secondary outcomes
The length of the segments, evaluated with standard and 3-D angiography, will be compared with the length of the segment measured with the marker guide-wire.
Each group of the same vessel(LAD, RCA, CX) will be evaluated separately.
All the QCA results of standard angiography will be compared with those of 3-D angiography, in particular in the segments where the lesion is.
The percentage of vessel foreshortening of the standard angiography operator-selected "working view" will be compared to the least foreshortened view automatically selected with the 3-D angiography reconstruction.
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 31 Oct 2007.
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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.
Pierfrancesco Agostoni, MD principal investigator
Antwerp Cardiovascular Institute Middelheim
Stefan Verheye, MD, PhD study chair
Antwerp Cardiovascular Institute Middelheim
Glenn Van Langenhove, MD, PhD study director
Antwerp Cardiovascular Institute Middelheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3-dimensional coronary angiography in people with Coronary Artery Disease, run by Antwerp Cardiovascular Institute Middelheim at 1 site in Belgium.
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 10 inclusion and 11 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 31 Oct 2007. 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 Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
standard coronary angiography over/underestimates the length of the coronary segment evaluated. (time frame: peri-procedural). It is what the study was designed to measure, not a finding.
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 31 Oct 2007.