Chronic Total Occlusion of Coronary ArteryNCT06113835
Viable Myocardium Detected by Hybrid PET/MR and SPECT for the Prediction of the Efficacy of PCI in Patients With CTO.
An observational study of Chronic Total Occlusion of Coronary Artery, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
CTO intervention is controversial, and viable myocardium is critical to the improvement of cardiac function and prognosis of patients. However, it remains uncertain whether viable myocardium detected by Hybrid PET/MR and SPECT Imaging improves the PCI efficacy in Patients With CTO. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- What is being tested?
- CTO PCI
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 22 Feb 2023to 30 Mar 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with symptomatic coronary artery disease (CAD) (angina or angina equivalent) in the presence of a CTO of a relevant coronary artery
Who may be able to join
- Age ≧ 18 years, < 75 years;
- complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ≥3 months;
- presence of angina or angina-equivalent symptoms ; undergo coronary intervention;
Who cannot join
- life expectancy < 1 year due to non-cardiac disease;
- contraindications to SPECT/PET/MRI: pregnancy, contrast allergy, claustrophobia, history of pacemaker and ICD implantation, other ferromagnetic materials in the body;
- acute coronary syndrome within the last 3 months;
- severe valvular heart disease;
- haemodynamic instability;
- hepatic or renal insufficiency, with alanine aminotransferase (ALT) > 3 times the upper limit of normal or glomerular filtration rate ≤ 30 mL/min;
Show all 9Show fewer
- two or more CTO lesions;
- previous myocardial infarction.
- Others who, in the opinion o f the investigator, should not be enrolled;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Fuming Zhang, M.D., +86-25-83718836 ext. 6360, jsphkj@163.com
Chai, M.D., +86-25-83718836 ext. 6360, jsphkj@163.com
About this study
Official title: Viable Myocardium Detected by the Combination of Hybrid PET/MR and SPECT Imaging for the Prediction of the Efficacy of PCI in Patients With Chronic Total Occlusion.
CTO intervention is controversial, and viable myocardium is critical to the improvement of cardiac function and prognosis of patients. However, it remains uncertain whether viable myocardium detected by Hybrid PET/MR and SPECT Imaging improves the PCI efficacy in Patients With CTO.
In this investigator-initiated, prospective, single-center, observational trial, patients meeting the inclusion/exclusion criteria would be assigned to the successful group or the unsuccessful group based on the success of PCI, both undergoing pre-operative and 6-month follow-up Hybrid PET/MR and SPECT imaging. The improvement of left ventricular (LV) recovery after 6 months will be observed.
Read the detailed description
Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) represents a major challenge in interventional cardiology. However, the results of the current large-scale CTO study showed that PCI failed to improve the long-term prognosis (MACE) over medical therapy. Is CTO intervention necessary and how to select appropriate patients for intervention? Previous studies have found the presence and improvement of viable myocardium(VM) in patients with CTO after PCI，and the amount of preoperative VM is critical to the choice of treatment for patients.
Several diagnostic techniques have been introduced to assess myocardial viability and LV recovery, allowing the identification of ischemic myocardium with potentially reversible systolic dysfunction, such as hibernating myocardium, among which 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography ( 18F-FDG PET) as the "gold standard" for clinical assessment of VM. However, single FDG-PET assessment of VM has limitations and cannot accurately identify hibernating myocardium. 99mTc-Methoxyisobutylisocyanide single-photon emission computed tomography (99mTc-MIBI SPECT), as a validated method for assessing myocardial perfusion, is recommended by guidelines for the assessment of VM in combination with FDG-PET. In recent years, contrast-enhanced cardiac magnetic resonance imaging (cardiac magnetic resonance imaging CMR) has been increasingly used to assess myocardial viability due to its high spatial resolution, which allows the acquisition of cardiac function and myocardial scarring.
However, there are fundamental differences between the two methods in assessing VM and LV function, with LGE-CMR primarily describing an increase in extracellular space associated with scar tissue, whereas FDG-PET uptake represents the true metabolic signals of viable cardiomyocytes. They are complementary.
Hybrid PET/MRI has recently been used as a novel modality for evaluating cardiac diseases, allowing a truly synchronous/simultaneous acquisition of complementary information such as high-resolution anatomy and myocardial metabolism in merged images. However, few studies about PET/MRI were done in patients with CTO.
Our study aims to investigate the effect of CTO-PCI by assessing VM detected by the combination of PET/MR and SPECT and to investigate the predictive value of viable myocardial area on the efficacy of CTO-PCI.
- Being tested
- CTO PCI
- Keywords
- Chronic Total Occlusion of Coronary Artery, viable myocardium, Hybrid PET/MR and SPECT Imaging, Percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTO PCIProcedure or surgery
percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| successful group | CTO PCI Technical success ,deployment of a balloon or stent with final antegrade TIMI flow grade 2 or 3, residual stenosis <30% , and no significant side branch occlusion. Receives: Procedure: CTO PCI | |
| unsuccessful group | CTO PCI Technical unsuccess Receives: Procedure: CTO PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular ejection fraction increased by ≥5%
PET/MR postoperative follow-up
Measured: 6±1 month
Segmental ventricular wall motion score decreased by ≥1
PET/MR postoperative follow-up
Measured: 6±1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start22 Feb 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Chunjian Li, Dr,PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113835
- Sponsor's protocol ID
- 022
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azzalini L, Jolicoeur EM, Pighi M, Millan X, Picard F, Tadros VX, Fortier A, L'Allier PL, Ly HQ. Epidemiology, Management Strategies, and Outcomes of Patients With Chronic Total Coronary Occlusion. Am J Cardiol. 2016 Oct 15;118(8):1128-1135. doi: 10.1016/j.amjcard.2016.07.023. Epub 2016 Jul 28.
PubMed 27561190Hamzaraj K, Kammerlander A, Gyongyosi M, Frey B, Distelmaier K, Graf S. Patient Selection and Clinical Indication for Chronic Total Occlusion Revascularization-A Workflow Focusing on Non-Invasive Cardiac Imaging. Life (Basel). 2022 Dec 20;13(1):4. doi: 10.3390/life13010004.
PubMed 36675954Mehran R, Claessen BE, Godino C, Dangas GD, Obunai K, Kanwal S, Carlino M, Henriques JP, Di Mario C, Kim YH, Park SJ, Stone GW, Leon MB, Moses JW, Colombo A; Multinational Chronic Total Occlusion Registry. Long-term outcome of percutaneous coronary intervention for chronic total occlusions. JACC Cardiovasc Interv. 2011 Sep;4(9):952-61. doi: 10.1016/j.jcin.2011.03.021.
PubMed 21939934Henriques JP, Hoebers LP, Ramunddal T, Laanmets P, Eriksen E, Bax M, Ioanes D, Suttorp MJ, Strauss BH, Barbato E, Nijveldt R, van Rossum AC, Marques KM, Elias J, van Dongen IM, Claessen BE, Tijssen JG, van der Schaaf RJ; EXPLORE Trial Investigators. Percutaneous Intervention for Concurrent Chronic Total Occlusions in Patients With STEMI: The EXPLORE Trial. J Am Coll Cardiol. 2016 Oct 11;68(15):1622-1632. doi: 10.1016/j.jacc.2016.07.744.
PubMed 27712774Ryan M, Morgan H, Chiribiri A, Nagel E, Cleland J, Perera D. Myocardial viability testing: all STICHed up, or about to be REVIVED? Eur Heart J. 2022 Jan 13;43(2):118-126. doi: 10.1093/eurheartj/ehab729.
PubMed 34791132Ling LF, Marwick TH, Flores DR, Jaber WA, Brunken RC, Cerqueira MD, Hachamovitch R. Identification of therapeutic benefit from revascularization in patients with left ventricular systolic dysfunction: inducible ischemia versus hibernating myocardium. Circ Cardiovasc Imaging. 2013 May 1;6(3):363-72. doi: 10.1161/CIRCIMAGING.112.000138. Epub 2013 Apr 17.
PubMed 23595888Allman KC. Noninvasive assessment myocardial viability: current status and future directions. J Nucl Cardiol. 2013 Aug;20(4):618-37; quiz 638-9. doi: 10.1007/s12350-013-9737-8. Epub 2013 Jun 15.
PubMed 23771636Dilsizian V, Bacharach SL, Beanlands RS, Bergmann SR, Delbeke D, Dorbala S, Gropler RJ, Knuuti J, Schelbert HR, Travin MI. ASNC imaging guidelines/SNMMI procedure standard for positron emission tomography (PET) nuclear cardiology procedures. J Nucl Cardiol. 2016 Oct;23(5):1187-1226. doi: 10.1007/s12350-016-0522-3. Epub 2016 Jul 8. No abstract available.
PubMed 27392702Kwong RY, Chan AK, Brown KA, Chan CW, Reynolds HG, Tsang S, Davis RB. Impact of unrecognized myocardial scar detected by cardiac magnetic resonance imaging on event-free survival in patients presenting with signs or symptoms of coronary artery disease. Circulation. 2006 Jun 13;113(23):2733-43. doi: 10.1161/CIRCULATIONAHA.105.570648. Epub 2006 Jun 5.
PubMed 16754804Vitadello T, Kunze KP, Nekolla SG, Langwieser N, Bradaric C, Weis F, Cassese S, Fusaro M, Hapfelmeier A, Lewalter T, Schwaiger M, Kastrati A, Laugwitz KL, Rischpler C, Ibrahim T. Hybrid PET/MR imaging for the prediction of left ventricular recovery after percutaneous revascularisation of coronary chronic total occlusions. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3074-3083. doi: 10.1007/s00259-020-04877-w. Epub 2020 May 30.
PubMed 32472438
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viable Myocardium Detected by the Combination of Hybrid PET/MR and SPECT Imaging for the Prediction of the Efficacy of PCI in Patients With Chronic Total Occlusion.
- ClinicalTrials.gov ID
- NCT06113835
- Acronym / sponsor ID
- 022
- Keywords
- Chronic Total Occlusion of Coronary Artery, viable myocardium, Hybrid PET/MR and SPECT Imaging, Percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 2 Nov 2023 (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.
CTO intervention is controversial, and viable myocardium is critical to the improvement of cardiac function and prognosis of patients. However, it remains uncertain whether viable myocardium detected by Hybrid PET/MR and SPECT Imaging improves the PCI efficacy in Patients With CTO.
In this investigator-initiated, prospective, single-center, observational trial, patients meeting the inclusion/exclusion criteria would be assigned to the successful group or the unsuccessful group based on the success of PCI, both undergoing pre-operative and 6-month follow-up Hybrid PET/MR and SPECT imaging. The improvement of left ventricular (LV) recovery after 6 months will be observed.
Detailed description
Percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) represents a major challenge in interventional cardiology. However, the results of the current large-scale CTO study showed that PCI failed to improve the long-term prognosis (MACE) over medical therapy. Is CTO intervention necessary and how to select appropriate patients for intervention? Previous studies have found the presence and improvement of viable myocardium(VM) in patients with CTO after PCI，and the amount of preoperative VM is critical to the choice of treatment for patients.
Several diagnostic techniques have been introduced to assess myocardial viability and LV recovery, allowing the identification of ischemic myocardium with potentially reversible systolic dysfunction, such as hibernating myocardium, among which 2-deoxy-2-[18F]fluoro-D-glucose positron emission tomography ( 18F-FDG PET) as the "gold standard" for clinical assessment of VM. However, single FDG-PET assessment of VM has limitations and cannot accurately identify hibernating myocardium. 99mTc-Methoxyisobutylisocyanide single-photon emission computed tomography (99mTc-MIBI SPECT), as a validated method for assessing myocardial perfusion, is recommended by guidelines for the assessment of VM in combination with FDG-PET. In recent years, contrast-enhanced cardiac magnetic resonance imaging (cardiac magnetic resonance imaging CMR) has been increasingly used to assess myocardial viability due to its high spatial resolution, which allows the acquisition of cardiac function and myocardial scarring.
However, there are fundamental differences between the two methods in assessing VM and LV function, with LGE-CMR primarily describing an increase in extracellular space associated with scar tissue, whereas FDG-PET uptake represents the true metabolic signals of viable cardiomyocytes. They are complementary.
Hybrid PET/MRI has recently been used as a novel modality for evaluating cardiac diseases, allowing a truly synchronous/simultaneous acquisition of complementary information such as high-resolution anatomy and myocardial metabolism in merged images. However, few studies about PET/MRI were done in patients with CTO.
Our study aims to investigate the effect of CTO-PCI by assessing VM detected by the combination of PET/MR and SPECT and to investigate the predictive value of viable myocardial area on the efficacy of CTO-PCI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| successful group | – | Procedure: CTO PCICTO PCI Technical success ,deployment of a balloon or stent with final antegrade TIMI flow grade 2 or 3, residual stenosis <30% , and no significant side branch occlusion. |
| unsuccessful group | – | Procedure: CTO PCICTO PCI Technical unsuccess |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with symptomatic coronary artery disease (CAD) (angina or angina equivalent) in the presence of a CTO of a relevant coronary artery
Key inclusion criteria (3 listed)
- Age ≧ 18 years, < 75 years;
- complete occlusion of the coronary artery, confirmed by coronary angiography with TIMI flow grade 0, and occlusion for ≥3 months;
- presence of angina or angina-equivalent symptoms ; undergo coronary intervention;
Key exclusion criteria (9 listed)
- life expectancy < 1 year due to non-cardiac disease;
- contraindications to SPECT/PET/MRI: pregnancy, contrast allergy, claustrophobia, history of pacemaker and ICD implantation, other ferromagnetic materials in the body;
- acute coronary syndrome within the last 3 months;
- severe valvular heart disease;
- haemodynamic instability;
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 |
|---|---|---|
| CTO PCIpercutaneous coronary intervention | Procedure or surgery | successful group, unsuccessful group |
Primary outcome
left ventricular ejection fraction increased by ≥5%
Time frame: 6±1 month
PET/MR postoperative follow-up
Segmental ventricular wall motion score decreased by ≥1
Time frame: 6±1 month
PET/MR postoperative follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- Background: PubMed 27561190Azzalini L, Jolicoeur EM, Pighi M, Millan X, Picard F, Tadros VX, Fortier A, L'Allier PL, Ly HQ. Epidemiology, Management Strategies, and Outcomes of Patients With Chronic Total Coronary Occlusion. Am J Cardiol. 2016 Oct 15;118(8):1128-1135. doi: 10.1016/j.amjcard.2016.07.023. Epub 2016 Jul 28.
- Background: PubMed 36675954Hamzaraj K, Kammerlander A, Gyongyosi M, Frey B, Distelmaier K, Graf S. Patient Selection and Clinical Indication for Chronic Total Occlusion Revascularization-A Workflow Focusing on Non-Invasive Cardiac Imaging. Life (Basel). 2022 Dec 20;13(1):4. doi: 10.3390/life13010004.
- Background: PubMed 21939934Mehran R, Claessen BE, Godino C, Dangas GD, Obunai K, Kanwal S, Carlino M, Henriques JP, Di Mario C, Kim YH, Park SJ, Stone GW, Leon MB, Moses JW, Colombo A; Multinational Chronic Total Occlusion Registry. Long-term outcome of percutaneous coronary intervention for chronic total occlusions. JACC Cardiovasc Interv. 2011 Sep;4(9):952-61. doi: 10.1016/j.jcin.2011.03.021.
- Background: PubMed 27712774Henriques JP, Hoebers LP, Ramunddal T, Laanmets P, Eriksen E, Bax M, Ioanes D, Suttorp MJ, Strauss BH, Barbato E, Nijveldt R, van Rossum AC, Marques KM, Elias J, van Dongen IM, Claessen BE, Tijssen JG, van der Schaaf RJ; EXPLORE Trial Investigators. Percutaneous Intervention for Concurrent Chronic Total Occlusions in Patients With STEMI: The EXPLORE Trial. J Am Coll Cardiol. 2016 Oct 11;68(15):1622-1632. doi: 10.1016/j.jacc.2016.07.744.
- Background: PubMed 34791132Ryan M, Morgan H, Chiribiri A, Nagel E, Cleland J, Perera D. Myocardial viability testing: all STICHed up, or about to be REVIVED? Eur Heart J. 2022 Jan 13;43(2):118-126. doi: 10.1093/eurheartj/ehab729.
- Background: PubMed 23595888Ling LF, Marwick TH, Flores DR, Jaber WA, Brunken RC, Cerqueira MD, Hachamovitch R. Identification of therapeutic benefit from revascularization in patients with left ventricular systolic dysfunction: inducible ischemia versus hibernating myocardium. Circ Cardiovasc Imaging. 2013 May 1;6(3):363-72. doi: 10.1161/CIRCIMAGING.112.000138. Epub 2013 Apr 17.
- Background: PubMed 23771636Allman KC. Noninvasive assessment myocardial viability: current status and future directions. J Nucl Cardiol. 2013 Aug;20(4):618-37; quiz 638-9. doi: 10.1007/s12350-013-9737-8. Epub 2013 Jun 15.
- Background: PubMed 27392702Dilsizian V, Bacharach SL, Beanlands RS, Bergmann SR, Delbeke D, Dorbala S, Gropler RJ, Knuuti J, Schelbert HR, Travin MI. ASNC imaging guidelines/SNMMI procedure standard for positron emission tomography (PET) nuclear cardiology procedures. J Nucl Cardiol. 2016 Oct;23(5):1187-1226. doi: 10.1007/s12350-016-0522-3. Epub 2016 Jul 8. No abstract available.
- Background: PubMed 16754804Kwong RY, Chan AK, Brown KA, Chan CW, Reynolds HG, Tsang S, Davis RB. Impact of unrecognized myocardial scar detected by cardiac magnetic resonance imaging on event-free survival in patients presenting with signs or symptoms of coronary artery disease. Circulation. 2006 Jun 13;113(23):2733-43. doi: 10.1161/CIRCULATIONAHA.105.570648. Epub 2006 Jun 5.
- Background: PubMed 32472438Vitadello T, Kunze KP, Nekolla SG, Langwieser N, Bradaric C, Weis F, Cassese S, Fusaro M, Hapfelmeier A, Lewalter T, Schwaiger M, Kastrati A, Laugwitz KL, Rischpler C, Ibrahim T. Hybrid PET/MR imaging for the prediction of left ventricular recovery after percutaneous revascularisation of coronary chronic total occlusions. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3074-3083. doi: 10.1007/s00259-020-04877-w. Epub 2020 May 30.
- 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.
Chunjian Li, Dr,PhD principal investigator
Study Principal Investigator
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 Chronic Total Occlusion of Coronary Artery, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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 China. 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?
Contact Chunjian Li, Dr,PhD (+86-13701465229, drcjli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular ejection fraction increased by ≥5% (time frame: 6±1 month). 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?
On the ClinicalTrials.gov record for NCT06113835, which also lists 10 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 2 Nov 2023; AzTrials last refreshed its copy on 8 Nov 2026.