Chronic Total Occlusion of Coronary ArteryNCT04060615
Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery CTO
A study testing percutaneous coronary intervention in people with Chronic Total Occlusion of Coronary Artery, run by University of Belgrade at 1 site in Serbia.
Trial summary
This study will evaluate the changes in myocardial microcirculatory parameters of the collateral donor artery after recanalization of coronary artery chronic total occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- What is being tested?
- percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSerbia
- Study dates
- 28 Mar 2017to 15 Jan 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 with signed informed consent to participate in the study
- Presence of one CTO on native coronary arteries (with TIMI 0 flow)
- Presence of clinical indication for attempting a PCI for CTO (at least one of the criteria present):
- Symptoms of typical stable angina
- Presence of inducible ischemia in the territory of the occluded artery
- Presence of viable myocardium in the territory of the occluded artery
- The diameter of the occluded artery ≥2.5mm
Who cannot join
- Acute coronary syndrome in the past month
- Existing contraindication for administration of dual antiplatelet therapy in the duration of 12 months
- Contraindications for implanting the drug-eluting stents
- Existence of 2 or more CTOs on native coronary arteries (with TIMI 0 flow)
- Severe tortuosity or calcifications of the coronary arteries
- Left ventricle aneurysm
Show all 15Show fewer
- Previous coronary artery bay-pass graft or any other cardiac surgery
- Previous myocardial infarction in the coronary artery territory different from the CTO
- Ejection fraction of the left ventricle less than 30%
- Permanent atrial fibrillation
- Pregnancy
- Patients with known allergy to iodine contrast that cannot be controlled with medication
- Patients who are unable or unwilling to cooperate and come for check-up visits
- Life expectancy less than a year
- Hemorrhagic diathesis, coagulopathy, or rejection of blood transfusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery Chronic Total Occlusion
This study will evaluate the changes in myocardial microcirculatory parameters of the collateral donor artery after recanalization of coronary artery chronic total occlusion.
Read the detailed description
This study will include patients with chronic total occlusion (CTO) of one coronary artery who will undergo the recanalization of the CTO. Before the procedure, myocardial viability, ischemia, functional parameters of the collateral donor blood vessels, echocardiography, and quality of life will be assessed. After the recanalization, these parameters will be assessed again 24h and 6 months after the procedure.
- Being tested
- percutaneous coronary intervention
- Keywords
- chronic total occlusion, coronary flow reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous coronary interventionProcedure or surgery
PCI of the chronic total occlusion of the coronary artery
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic total occlusion of the coronary artery | Other | In each patient before the PCI procedure, the investigators will assess myocardial viability, functional parameters of collateral blood vessels, and quality of life. 24h and 6 months after the procedure these parameters will be reevaluated as well as functional parameters of the treated coronary artery. Receives: Procedure: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary flow reserve
Change in coronary flow reserve of the collateral donor vessel (after PCI as compared to values before PCI) will be regarded as primary outcome measure
Measured: six months
Secondary outcomes (3)
Coronary flow velocity reserve
Correlation of coronary flow velocity reserve change of the collateral donor vessel (after PCI as compared to values before PCI) with viability measured by the percentage of viable myocardium on Single Photon Emission Computed Tomography (SPECT) of myocardial perfusion.
Measured: six months
Wall Motion Score Index (WMSI)
Relation of coronary flow velocity reserve change with wall motion score index on stres-echocardyography test where the wall motion segment abnormalities will be graded as such: 1 - normokinesis, 2 - hypokinesis, 3- akinesis and 4 dyskinesis, and the higher values indicates worse outcome
Measured: six months
Change from Baseline Stable Angina questionnaire (SAQ) at 6 months
Relation of coronary flow velocity reserve change with the quality of life measured by 19-item Seattle Angina Questionnaire that assesses angina frequency (with 9 questions where answers range from 1 to 6, the total score ranges from 0 to 100, where the higher value indicates better outcome), angina stability ( with 1 question where answers range from 1 to 6, the total score ranges from 0 to 100, where the higher value indicates better outcome), the angina frequency scale (with 2 questions where answers range from 1 to 5, the total score ranges from 0 to 100, where the higher value indicates better outcome), treatment satisfaction (with 4 questions where answers range from 1 to 6, the total score ranges from 0 to 100, where the higher value indicates better outcome), and disease perception/QoL (with 3 questions where answers range from 1 to 5, the total score ranges from 0 to 100, where the higher value indicates better outcome)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start28 Mar 2017
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients with chronic total occlusion will undergo the PCI procedure of the occlusion.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Centre of Serbia
- Responsible party
- Principal investigator, Milan Dobric, University of Belgrade
- Investigators
- Branko D Beleslin, MD, PhD, Study director, University of BelgradeMiodrag C Ostojic, MD, PhD, Study director, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060615
- Sponsor's protocol ID
- 61206-1296/2-17
- Status last verified
- Sep 2019
- First submitted
- 4 Aug 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sianos G, Werner GS, Galassi AR, Papafaklis MI, Escaned J, Hildick-Smith D, Christiansen EH, Gershlick A, Carlino M, Karlas A, Konstantinidis NV, Tomasello SD, Di Mario C, Reifart N; EuroCTO Club. Recanalisation of chronic total coronary occlusions: 2012 consensus document from the EuroCTO club. EuroIntervention. 2012 May 15;8(1):139-45. doi: 10.4244/EIJV8I1A21. No abstract available.
PubMed 22580257Delacretaz E, Meier B. Therapeutic strategy with total coronary artery occlusions. Am J Cardiol. 1997 Jan 15;79(2):185-7. doi: 10.1016/s0002-9149(96)00710-2.
PubMed 9193021Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065.
PubMed 15842978Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.
PubMed 19294443Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.
PubMed 22402070Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, Nasu K, Ehara M, Asakura Y, Katoh O, Suzuki T. Procedural and in-hospital outcomes after percutaneous coronary intervention for chronic total occlusions of coronary arteries 2002 to 2008: impact of novel guidewire techniques. JACC Cardiovasc Interv. 2009 Jun;2(6):489-97. doi: 10.1016/j.jcin.2009.04.008.
PubMed 19539251Saito S. Progress in angioplasty for chronic total occlusions again. Catheter Cardiovasc Interv. 2010 Nov 15;76(6):850-1. doi: 10.1002/ccd.22847. No abstract available.
PubMed 21104774Godino C, Sharp AS, Carlino M, Colombo A. Crossing CTOs-the tips, tricks, and specialist kit that can mean the difference between success and failure. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1019-46. doi: 10.1002/ccd.22161.
PubMed 19950136Werner GS. The role of coronary collaterals in chronic total occlusions. Curr Cardiol Rev. 2014 Feb;10(1):57-64. doi: 10.2174/1573403x10666140311123814.
PubMed 24611646Werner GS, Bahrmann P, Mutschke O, Emig U, Betge S, Ferrari M, Figulla HR. Determinants of target vessel failure in chronic total coronary occlusions after stent implantation. The influence of collateral function and coronary hemodynamics. J Am Coll Cardiol. 2003 Jul 16;42(2):219-25. doi: 10.1016/s0735-1097(03)00624-7.
PubMed 12875755Werner GS, Surber R, Kuethe F, Emig U, Schwarz G, Bahrmann P, Figulla HR. Collaterals and the recovery of left ventricular function after recanalization of a chronic total coronary occlusion. Am Heart J. 2005 Jan;149(1):129-37. doi: 10.1016/j.ahj.2004.04.042.
PubMed 15660044Werner GS, Surber R, Ferrari M, Fritzenwanger M, Figulla HR. The functional reserve of collaterals supplying long-term chronic total coronary occlusions in patients without prior myocardial infarction. Eur Heart J. 2006 Oct;27(20):2406-12. doi: 10.1093/eurheartj/ehl270. Epub 2006 Sep 26.
PubMed 17003048Werner GS, Fritzenwanger M, Prochnau D, Schwarz G, Ferrari M, Aarnoudse W, Pijls NH, Figulla HR. Determinants of coronary steal in chronic total coronary occlusions donor artery, collateral, and microvascular resistance. J Am Coll Cardiol. 2006 Jul 4;48(1):51-8. doi: 10.1016/j.jacc.2005.11.093. Epub 2006 Jun 12.
PubMed 16814648Werner GS, Ferrari M, Heinke S, Kuethe F, Surber R, Richartz BM, Figulla HR. Angiographic assessment of collateral connections in comparison with invasively determined collateral function in chronic coronary occlusions. Circulation. 2003 Apr 22;107(15):1972-7. doi: 10.1161/01.CIR.0000061953.72662.3A. Epub 2003 Mar 24.
PubMed 12665484Werner GS, Richartz BM, Gastmann O, Ferrari M, Figulla HR. Immediate changes of collateral function after successful recanalization of chronic total coronary occlusions. Circulation. 2000 Dec 12;102(24):2959-65. doi: 10.1161/01.cir.102.24.2959.
PubMed 11113046
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery Chronic Total Occlusion
- ClinicalTrials.gov ID
- NCT04060615
- Acronym / sponsor ID
- 61206-1296/2-17
- Keywords
- chronic total occlusion, coronary flow reserve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Collaborators
- Clinical Centre of Serbia
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 19 Aug 2019 (actual)
- 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.
This study will evaluate the changes in myocardial microcirculatory parameters of the collateral donor artery after recanalization of coronary artery chronic total occlusion.
Detailed description
This study will include patients with chronic total occlusion (CTO) of one coronary artery who will undergo the recanalization of the CTO. Before the procedure, myocardial viability, ischemia, functional parameters of the collateral donor blood vessels, echocardiography, and quality of life will be assessed. After the recanalization, these parameters will be assessed again 24h and 6 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients with chronic total occlusion will undergo the PCI procedure of the occlusion.
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic total occlusion of the coronary artery | Other | Procedure: percutaneous coronary interventionIn each patient before the PCI procedure, the investigators will assess myocardial viability, functional parameters of collateral blood vessels, and quality of life. 24h and 6 months after the procedure these parameters will be reevaluated as well as functional parameters of the treated coronary artery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over the age of 18 with signed informed consent to participate in the study
- Presence of one CTO on native coronary arteries (with TIMI 0 flow)
- Presence of clinical indication for attempting a PCI for CTO (at least one of the criteria present):
- The diameter of the occluded artery ≥2.5mm
Key exclusion criteria (15 listed)
- Acute coronary syndrome in the past month
- Existing contraindication for administration of dual antiplatelet therapy in the duration of 12 months
- Contraindications for implanting the drug-eluting stents
- Existence of 2 or more CTOs on native coronary arteries (with TIMI 0 flow)
- Severe tortuosity or calcifications of the coronary arteries
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 |
|---|---|---|
| percutaneous coronary interventionPCI of the chronic total occlusion of the coronary artery | Procedure or surgery | Patients with chronic total occlusion of the coronary artery |
Primary outcome
Coronary flow reserve
Time frame: six months
Change in coronary flow reserve of the collateral donor vessel (after PCI as compared to values before PCI) will be regarded as primary outcome measure
3 secondary outcomes
Coronary flow velocity reserve
Time frame: six months
Wall Motion Score Index (WMSI)
Time frame: six months
Change from Baseline Stable Angina questionnaire (SAQ) at 6 months
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 22580257Sianos G, Werner GS, Galassi AR, Papafaklis MI, Escaned J, Hildick-Smith D, Christiansen EH, Gershlick A, Carlino M, Karlas A, Konstantinidis NV, Tomasello SD, Di Mario C, Reifart N; EuroCTO Club. Recanalisation of chronic total coronary occlusions: 2012 consensus document from the EuroCTO club. EuroIntervention. 2012 May 15;8(1):139-45. doi: 10.4244/EIJV8I1A21. No abstract available.
- Background: PubMed 9193021Delacretaz E, Meier B. Therapeutic strategy with total coronary artery occlusions. Am J Cardiol. 1997 Jan 15;79(2):185-7. doi: 10.1016/s0002-9149(96)00710-2.
- Background: PubMed 15842978Christofferson RD, Lehmann KG, Martin GV, Every N, Caldwell JH, Kapadia SR. Effect of chronic total coronary occlusion on treatment strategy. Am J Cardiol. 2005 May 1;95(9):1088-91. doi: 10.1016/j.amjcard.2004.12.065.
- Background: PubMed 19294443Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.
- Background: PubMed 22402070Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.
- Background: PubMed 19539251Rathore S, Matsuo H, Terashima M, Kinoshita Y, Kimura M, Tsuchikane E, Nasu K, Ehara M, Asakura Y, Katoh O, Suzuki T. Procedural and in-hospital outcomes after percutaneous coronary intervention for chronic total occlusions of coronary arteries 2002 to 2008: impact of novel guidewire techniques. JACC Cardiovasc Interv. 2009 Jun;2(6):489-97. doi: 10.1016/j.jcin.2009.04.008.
- Background: PubMed 21104774Saito S. Progress in angioplasty for chronic total occlusions again. Catheter Cardiovasc Interv. 2010 Nov 15;76(6):850-1. doi: 10.1002/ccd.22847. No abstract available.
- Background: PubMed 19950136Godino C, Sharp AS, Carlino M, Colombo A. Crossing CTOs-the tips, tricks, and specialist kit that can mean the difference between success and failure. Catheter Cardiovasc Interv. 2009 Dec 1;74(7):1019-46. doi: 10.1002/ccd.22161.
- Background: PubMed 24611646Werner GS. The role of coronary collaterals in chronic total occlusions. Curr Cardiol Rev. 2014 Feb;10(1):57-64. doi: 10.2174/1573403x10666140311123814.
- Background: PubMed 12875755Werner GS, Bahrmann P, Mutschke O, Emig U, Betge S, Ferrari M, Figulla HR. Determinants of target vessel failure in chronic total coronary occlusions after stent implantation. The influence of collateral function and coronary hemodynamics. J Am Coll Cardiol. 2003 Jul 16;42(2):219-25. doi: 10.1016/s0735-1097(03)00624-7.
- Background: PubMed 15660044Werner GS, Surber R, Kuethe F, Emig U, Schwarz G, Bahrmann P, Figulla HR. Collaterals and the recovery of left ventricular function after recanalization of a chronic total coronary occlusion. Am Heart J. 2005 Jan;149(1):129-37. doi: 10.1016/j.ahj.2004.04.042.
- Background: PubMed 17003048Werner GS, Surber R, Ferrari M, Fritzenwanger M, Figulla HR. The functional reserve of collaterals supplying long-term chronic total coronary occlusions in patients without prior myocardial infarction. Eur Heart J. 2006 Oct;27(20):2406-12. doi: 10.1093/eurheartj/ehl270. Epub 2006 Sep 26.
- Individual participant dataSharing planned: No
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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.
Branko D Beleslin, MD, PhD study director
University of Belgrade
Miodrag C Ostojic, MD, PhD study director
University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous coronary intervention in people with Chronic Total Occlusion of Coronary Artery, run by University of Belgrade at 1 site in Serbia.
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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. 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 Serbia. 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?
Results are not available in the source record.
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?
Coronary flow reserve (time frame: six months). 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 NCT04060615, which also lists 42 linked publications.
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 Sep 2019.