Stable Coronary Artery DiseaseNCT01205425
Computed Tomography Coronary Angiography Before Stent Implantation
A study testing PCI on the basis of coronary angiography and CT guided PCI in people with Stable Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
Trial summary
The purpose of the study is to determine whether results of the computed tomography coronary angiography may be helpful in planning and performing percutaneous angioplasty in patients with stable angina pectoris. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stable Coronary Artery Disease
- What is being tested?
- PCI on the basis of coronary angiography and CT guided PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2009to Jun 2011
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable coronary artery disease
- Planned stent implantation into single lesion in native coronary artery
- Planned stent diameter: 2.5-4.0 mm
Who cannot join
- Women younger than 50 years
- Lesion location in left main coronary artery
- Atrial fibrilation or other significant arrythmia
- Severe chronic obturatory pulmonary disease
- Hyperthyroidism
- Known allergy to contrast media
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- Glomerular filtration rate < 30
- Treatment of bifurcation lesion
- Stent implantation for in-stent restenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Computed Tomography Coronary Angiography in Optimalization of Percutaneous Coronary Interventions With Stent Implantation.
The purpose of the study is to determine whether results of the computed tomography coronary angiography may be helpful in planning and performing percutaneous angioplasty in patients with stable angina pectoris.
Read the detailed description
Currently most percutaneous coronary interventions (PCI) are planned and performed on the basis of invasive coronary angiography which provides the information that is confined to the vessel lumen. This limitation may be partially responsible for the unfavorable long term outcome and complications that occur in some patients. Additional information on the disease burden in angiographically normal coronary segments adjacent to the lesion site could impact the treatment strategy and clinical results. Imaging modalities that allow not only lumen but also vessel wall assessment include both invasive (e.g. intravascular ultrasounds - IVUS) and non-invasive (e.g. multislice computed tomography - MSCT) methods. IVUS guidance of the coronary interventions is expensive and given its invasiveness is related to the additional risk. The number of patients who are referred for coronary angiography with significant stenosis diagnosed with MSCT is rapidly increasing. Most interventional cardiologists are not familiar with coronary vessel images produced by MSCT. The aim of our study is to assess if the analyses of MSCT images before the PCI may impact the treatment strategy and immediate results. The study will enroll subjects with significant coronary stenosis diagnosed with MSCT who are referred to the catheterisation laboratory for invasive angiography and PCI. The study participants will be randomized into two groups:
Group 1 - the results of MSCT are analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation) Group 2 - interventional cardiologist is blinded to the images obtained by MSCT. The PCI procedure is performed solely on the basis of invasive coronary angiography In both study groups IVUS will be performed before and after stent implantation. The operator will be blinded to the results of pre-PCI IVUS. The second IVUS will be performed when angiographic results are optimal in the opinion of the operator. The results of the second IVUS examination will be the efficacy measure of the two compared treatment strategies.
- Conditions
- Stable Coronary Artery Disease
- Being tested
- PCI on the basis of coronary angiography, CT guided PCI
- Keywords
- Computed coronary angiography, Stent implantation, IVUS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI on the basis of coronary angiographyOther
Interventional cardiologist will be blinded to the images obtained by CT. The PCI procedure will be planned and performed solely on the basis of invasive coronary angiography
CT guided PCIProcedure or surgery
The results of the CT scan will be analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation)
| Study group | Role | What they receive |
|---|---|---|
| CT | Experimental | Procedure of stent implantation will be planed on the basis of both angiography and computed tomography results. Receives: Procedure: CT guided PCI |
| Angio | Active comparator | Procedure of stent implantation will be planned only on the basis of diagnostic coronary angiography. Receives: Other: PCI on the basis of coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal in stent lumen area as assessed by IVUS
Measured: Up to 10 minutes after stent implantation
Adequacy of lesion coverage defined as minimal lumen area in reference segments adjacent to stent shoulder.
Measured: Up to 10 minutes after stent implantation
Secondary outcomes (3)
Mean stent lumen area
Measured: Up to 10 minutes after stent implantation
Mean lumen area and plaque and media area in 10mm segments adjucent to stent edges.
Measured: Up to 10 minutes after stent implantation
Qualitative and quantitative assessment of potential complications (tissue prolaps, plaque shift, stent edge dissection and stent malapossition)
Measured: Up to 10 minutes after stent implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerstwo Nauki i Szkolnictwa Wyższego, Warszawa, Polska
- Investigators
- Jerzy Pregowski, MD, Principal investigator, National Institute of Cardiology, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205425
- Sponsor's protocol ID
- N N403 295736
- Status last verified
- Jul 2011
- First submitted
- 25 Jun 2010
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Computed Tomography Coronary Angiography in Optimalization of Percutaneous Coronary Interventions With Stent Implantation.
- ClinicalTrials.gov ID
- NCT01205425
- Acronym / sponsor ID
- N N403 295736
- Conditions
- Stable Coronary Artery Disease
- Keywords
- Computed coronary angiography, Stent implantation, IVUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Ministerstwo Nauki i Szkolnictwa Wyższego, Warszawa, Polska
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Sep 2010 (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 purpose of the study is to determine whether results of the computed tomography coronary angiography may be helpful in planning and performing percutaneous angioplasty in patients with stable angina pectoris.
Detailed description
Currently most percutaneous coronary interventions (PCI) are planned and performed on the basis of invasive coronary angiography which provides the information that is confined to the vessel lumen. This limitation may be partially responsible for the unfavorable long term outcome and complications that occur in some patients. Additional information on the disease burden in angiographically normal coronary segments adjacent to the lesion site could impact the treatment strategy and clinical results. Imaging modalities that allow not only lumen but also vessel wall assessment include both invasive (e.g. intravascular ultrasounds - IVUS) and non-invasive (e.g. multislice computed tomography - MSCT) methods. IVUS guidance of the coronary interventions is expensive and given its invasiveness is related to the additional risk. The number of patients who are referred for coronary angiography with significant stenosis diagnosed with MSCT is rapidly increasing. Most interventional cardiologists are not familiar with coronary vessel images produced by MSCT. The aim of our study is to assess if the analyses of MSCT images before the PCI may impact the treatment strategy and immediate results. The study will enroll subjects with significant coronary stenosis diagnosed with MSCT who are referred to the catheterisation laboratory for invasive angiography and PCI. The study participants will be randomized into two groups:
Group 1 - the results of MSCT are analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation) Group 2 - interventional cardiologist is blinded to the images obtained by MSCT. The PCI procedure is performed solely on the basis of invasive coronary angiography In both study groups IVUS will be performed before and after stent implantation. The operator will be blinded to the results of pre-PCI IVUS. The second IVUS will be performed when angiographic results are optimal in the opinion of the operator. The results of the second IVUS examination will be the efficacy measure of the two compared treatment strategies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT | Experimental | Procedure: CT guided PCIProcedure of stent implantation will be planed on the basis of both angiography and computed tomography results. |
| Angio | Active comparator | Other: PCI on the basis of coronary angiographyProcedure of stent implantation will be planned only on the basis of diagnostic coronary angiography. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Stable coronary artery disease
- Planned stent implantation into single lesion in native coronary artery
- Planned stent diameter: 2.5-4.0 mm
Key exclusion criteria (9 listed)
- Women younger than 50 years
- Lesion location in left main coronary artery
- Atrial fibrilation or other significant arrythmia
- Severe chronic obturatory pulmonary disease
- Hyperthyroidism
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 |
|---|---|---|
| PCI on the basis of coronary angiographyInterventional cardiologist will be blinded to the images obtained by CT. The PCI procedure will be planned and performed solely on the basis of invasive coronary angiography | Other | Angio |
| CT guided PCIThe results of the CT scan will be analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation) | Procedure or surgery | CT |
Primary outcome
Minimal in stent lumen area as assessed by IVUS
Time frame: Up to 10 minutes after stent implantation
Adequacy of lesion coverage defined as minimal lumen area in reference segments adjacent to stent shoulder.
Time frame: Up to 10 minutes after stent implantation
3 secondary outcomes
Mean stent lumen area
Time frame: Up to 10 minutes after stent implantation
Mean lumen area and plaque and media area in 10mm segments adjucent to stent edges.
Time frame: Up to 10 minutes after stent implantation
Qualitative and quantitative assessment of potential complications (tissue prolaps, plaque shift, stent edge dissection and stent malapossition)
Time frame: Up to 10 minutes after stent implantation
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 6 Jul 2011.
- Web page of Institute of Cardiology, WarsawLink provided by the sponsor.
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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.
Jerzy Pregowski, MD principal investigator
National Institute of Cardiology, Warsaw, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI on the basis of coronary angiography and CT guided PCI in people with Stable Coronary Artery Disease, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.
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 3 inclusion and 9 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 6 Jul 2011. 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 Poland. 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?
Minimal in stent lumen area as assessed by IVUS (time frame: Up to 10 minutes after stent implantation). The study lists 2 primary outcomes in all. 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 6 Jul 2011; AzTrials last refreshed its copy on 3 Nov 2026.