Chronic Total Occlusion (CTO)FACTNCT06655922
FAPI Imaging Assessment of Chronic Total Occlusion
An observational study of Chronic Total Occlusion (CTO), run by Lin Zhao at 2 sites in China.
Trial summary
This registry will include consecutive patients presenting with at least one chronic total coronary occlusion (CTO) identified via coronary angiography or cardiac computed tomography angiography (CCTA) at our center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion (CTO)
- What is being tested?
- FAPI Imaging
- How many people
- 167 participants
- Where
- 2 sitesChina
- Study dates
- 10 Sep 2024to 31 Aug 2026
- How long will I take part?
- 2 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with at least one coronary chronic total occlusion (CTO) on coronary angiogram who will be treated by percutaneous coronary intervention
Who may be able to join
- Age \> 18 years
- Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches [reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old
- Patient has a clinical indication to perform CTO PCI
- Willing to participate and able to understand, read and sign the informed consent document.
Who cannot join
- Hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents
- Severe hepatic dysfunction (≥3 times normal reference values)
- Severe chronic kidney disease (estimated Glomerular Filtration Rate [eGFR] \<30 mL/min/1.73m2)
- Life expectancy \< 1 years
- Pregnant women or women with potential childbearing
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
Beijing, Beijing Municipality, 100020
Shengwen Yang, Ph.D MD, +86-17801014018 ext. +8685231480, verayang1990@163.com
- Recruiting
Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
Beijing, Beijing Municipality, 100020
Shengwen Yang, Ph.D MD, +8601085231480, verayang1990@163.com
About this study
Official title: The Clinical Value of FAPI Imaging in Assessing Chronic Total Occlusion Lesions in Patients with Coronary Heart Disease (FACT Trial)
This registry will include consecutive patients presenting with at least one chronic total coronary occlusion (CTO) identified via coronary angiography or cardiac computed tomography angiography (CCTA) at our center. Due to the complexity of CTO lesions, both procedural success rates and prognosis improvements are limited. The progression and development of atherosclerotic plaques involve fibroblast activity, contributing to the formation of fibrous caps and calcified nodules through various mechanisms. Myocardial fibrosis within chronically occluded segments is strongly linked to ventricular remodeling and patient prognosis. The activation of cardiac fibroblasts (CFs) is a critical early phase in myocardial fibrosis, playing a key role in fibrotic progression. However, the role of activated CFs in CTO patients has remained unclear, mainly due to the lack of reliable in vivo assessment techniques for detecting CF activation.
Recent studies have demonstrated that radionuclide-labeled fibroblast activation protein inhibitor (FAPI) imaging is an effective and reliable technique for detecting both myocardial fibrosis and activated CFs in arterial plaques. Preliminary data suggest that FAPI imaging can characterize plaque composition and assess the extent of myocardial fibrosis in various cardiovascular conditions. However, its potential to predict the ease of CTO recanalization and subsequent clinical outcomes remains to be fully explored.
Read more
The aim of this prospective cohort study is to evaluate the predictive value of FAPI imaging in patients with at least one untreated CTO. All enrolled patients will undergo baseline assessments prior to intervention, including blood tests, clinical evaluations, and imaging studies. These imaging studies will include myocardial FDG/perfusion imaging, FAPI imaging, and resting perfusion imaging. In selected patients, additional evaluations such as stress myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography will also be performed.
For patients undergoing percutaneous coronary intervention (PCI), follow-up assessments will occur at 6 and 12 months. At the 6-month mark, improvements in left ventricular (LV) wall motion will be assessed using resting perfusion imaging. At 12 months, coronary angiography (CAG) will be performed on all patients to evaluate recanalization outcomes. Additionally, myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography may be selectively used to evaluate patients during the 12-month follow-up.
- To evaluate the ability of FAPI imaging in predicting the difficulty of CTO recanalization.
- To investigate the role of myocardial FAPI imaging in predicting the improvement of LV wall motion at 6 months, assessed using follow-up single-photon emission computed tomography (SPECT).
By comparing FAPI imaging with conventional prognostic assessment methods, this study aims to clarify the utility of FAPI imaging in both predicting the recanalization complexity and in assessing long-term clinical outcomes in CTO patients.
- Conditions
- Chronic Total Occlusion (CTO)
- Being tested
- FAPI Imaging
- Keywords
- Coronary Heart Disease, Fibroblast activation protein inhibitor, Percutaneous coronary intervention, Imaging, Prognosis
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI ImagingDiagnostic test
Studies have shown that imaging with radionuclide-labeled fibroblast activation protein inhibitor (FAPI) is a reliable technique for detecting myocardial fibrosis and activated CFs in arteries. Preliminary evidence suggests that FAPI imaging can assess plaque characteristics and the status of myocardial fibrosis in various cardiovascular diseases.
| Study group | Role | What they receive |
|---|---|---|
| Patients with at least one untreated CTO at basal angiography | Total occlusion in any major coronary vessel or relevant side branches [reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old Receives: Diagnostic Test: FAPI Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of left ventricular (LV) wall motion
SPECT images (myocardial perfusion imaging, MPI) were analyzed using QPS/QGS software. Segmental wall motion was semi-quantitatively scored using the American Heart Association (AHA) 17-segment LV model and a five-point scale. 0=normal, 1=mildly hypokinetic, 2=moderately hypokinetic, 3=severely hypokinetic, 4=akinetic, 5=dyskinetic. The improvement of LV wall motion was defined as a decrease of the wall motion score of at least 1 point score.
Measured: 6 months after the procedure
Secondary outcomes (4)
LV end-systolic volume (ml)
LV function was assessed by modified Simpson's method.Volumes were obtained by delineation of inner and outer LV contours in end-systolic frames on cardiac SPECT, echocardiography or cardiac magnetic resonance.
Measured: 6 months and 12 months after the procedure
LV end-diastolic volume (ml)
LV function was assessed by modified Simpson's method. LV end-diastolic volume was obtained by delineation of inner and outer LV contours in end-diastolic frames on cardiac SPECT, echocardiography or cardiac magnetic resonance.
Measured: 6 months and 12 months after the procedure
LV ejection fraction (%)
LV function was assessed by modified Simpson's method. Ejection fraction (EF) was computed from the EDV and ESV as follows:EF=EDV-ESV/EDV on cardiac SPECT, echocardiography or cardiac MRI.
Measured: 6 months and 12 months after the procedure.
Procedural success
Procedural success was defined as successful recanalization of the intended CTO lesion with DES implantation, restoration of Thrombolysis In Myocardial Infarction flow grade 3, and residual diameter stenosis <30% on visual assessment.
Measured: immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start10 Sep 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Total Occlusion (CTO)Studies 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
- 167 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Lin Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital
- Responsible party
- Sponsor-investigator, Lin Zhao, Beijing Chao Yang Hospital
- Investigators
- Lin Zhao, Ph.D MD, Principal investigator, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655922
- Sponsor's protocol ID
- 2024-772-1
- Acronym
- FACT
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Publications
Panza JA, Ellis AM, Al-Khalidi HR, Holly TA, Berman DS, Oh JK, Pohost GM, Sopko G, Chrzanowski L, Mark DB, Kukulski T, Favaloro LE, Maurer G, Farsky PS, Tan RS, Asch FM, Velazquez EJ, Rouleau JL, Lee KL, Bonow RO. Myocardial Viability and Long-Term Outcomes in Ischemic Cardiomyopathy. N Engl J Med. 2019 Aug 22;381(8):739-748. doi: 10.1056/NEJMoa1807365.
PubMed 31433921Perera D, Clayton T, Petrie MC, Greenwood JP, O'Kane PD, Evans R, Sculpher M, Mcdonagh T, Gershlick A, de Belder M, Redwood S, Carr-White G, Marber M; REVIVED investigators. Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial: Percutaneous Coronary Intervention for Ischemic Cardiomyopathy. JACC Heart Fail. 2018 Jun;6(6):517-526. doi: 10.1016/j.jchf.2018.01.024.
PubMed 29852933Wang L, Wang Y, Wang J, Xiao M, Xi XY, Chen BX, Su Y, Zhang Y, Xie B, Dong Z, Zhao S, Yang MF. Myocardial Activity at 18F-FAPI PET/CT and Risk for Sudden Cardiac Death in Hypertrophic Cardiomyopathy. Radiology. 2023 Feb;306(2):e221052. doi: 10.1148/radiol.221052. Epub 2022 Oct 11.
PubMed 36219116
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Value of FAPI Imaging in Assessing Chronic Total Occlusion Lesions in Patients with Coronary Heart Disease (FACT Trial)
- ClinicalTrials.gov ID
- NCT06655922
- Acronym / sponsor ID
- FACT / 2024-772-1
- Conditions
- Chronic Total Occlusion (CTO)
- Keywords
- Coronary Heart Disease, Fibroblast activation protein inhibitor, Percutaneous coronary intervention, Imaging, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Lin ZhaoUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 24 Oct 2024 (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 registry will include consecutive patients presenting with at least one chronic total coronary occlusion (CTO) identified via coronary angiography or cardiac computed tomography angiography (CCTA) at our center. Due to the complexity of CTO lesions, both procedural success rates and prognosis improvements are limited. The progression and development of atherosclerotic plaques involve fibroblast activity, contributing to the formation of fibrous caps and calcified nodules through various mechanisms. Myocardial fibrosis within chronically occluded segments is strongly linked to ventricular remodeling and patient prognosis. The activation of cardiac fibroblasts (CFs) is a critical early phase in myocardial fibrosis, playing a key role in fibrotic progression. However, the role of activated CFs in CTO patients has remained unclear, mainly due to the lack of reliable in vivo assessment techniques for detecting CF activation.
Recent studies have demonstrated that radionuclide-labeled fibroblast activation protein inhibitor (FAPI) imaging is an effective and reliable technique for detecting both myocardial fibrosis and activated CFs in arterial plaques. Preliminary data suggest that FAPI imaging can characterize plaque composition and assess the extent of myocardial fibrosis in various cardiovascular conditions. However, its potential to predict the ease of CTO recanalization and subsequent clinical outcomes remains to be fully explored.
The aim of this prospective cohort study is to evaluate the predictive value of FAPI imaging in patients with at least one untreated CTO. All enrolled patients will undergo baseline assessments prior to intervention, including blood tests, clinical evaluations, and imaging studies. These imaging studies will include myocardial FDG/perfusion imaging, FAPI imaging, and resting perfusion imaging. In selected patients, additional evaluations such as stress myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography will also be performed.
For patients undergoing percutaneous coronary intervention (PCI), follow-up assessments will occur at 6 and 12 months. At the 6-month mark, improvements in left ventricular (LV) wall motion will be assessed using resting perfusion imaging. At 12 months, coronary angiography (CAG) will be performed on all patients to evaluate recanalization outcomes. Additionally, myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography may be selectively used to evaluate patients during the 12-month follow-up.
- To evaluate the ability of FAPI imaging in predicting the difficulty of CTO recanalization.
- To investigate the role of myocardial FAPI imaging in predicting the improvement of LV wall motion at 6 months, assessed using follow-up single-photon emission computed tomography (SPECT).
By comparing FAPI imaging with conventional prognostic assessment methods, this study aims to clarify the utility of FAPI imaging in both predicting the recanalization complexity and in assessing long-term clinical outcomes in CTO patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with at least one untreated CTO at basal angiography | – | Diagnostic Test: FAPI ImagingTotal occlusion in any major coronary vessel or relevant side branches [reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with at least one coronary chronic total occlusion (CTO) on coronary angiogram who will be treated by percutaneous coronary intervention
Key inclusion criteria (4 listed)
- Age \> 18 years
- Presence of at least one untreated CTO at basal angiography (defined as a total occlusion in any major coronary vessel or relevant side branches [reference vessel diameter ≥2.5mm or as judged by two independent interventional cardiologists], with TIMI 0 in the distal segment and at least 3 months old
- Patient has a clinical indication to perform CTO PCI
- Willing to participate and able to understand, read and sign the informed consent document.
Key exclusion criteria (5 listed)
- Hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents
- Severe hepatic dysfunction (≥3 times normal reference values)
- Severe chronic kidney disease (estimated Glomerular Filtration Rate [eGFR] \<30 mL/min/1.73m2)
- Life expectancy \< 1 years
- Pregnant women or women with potential childbearing
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 |
|---|---|---|
| FAPI ImagingStudies have shown that imaging with radionuclide-labeled fibroblast activation protein inhibitor (FAPI) is a reliable technique for detecting myocardial fibrosis and activated CFs in arteries. Preliminary evidence suggests that FAPI imaging can assess plaque characteristics and the status of myocardial fibrosis in various cardiovascular diseases. | Diagnostic test | Patients with at least one untreated CTO at basal angiography |
Primary outcome
Improvement of left ventricular (LV) wall motion
Time frame: 6 months after the procedure
SPECT images (myocardial perfusion imaging, MPI) were analyzed using QPS/QGS software. Segmental wall motion was semi-quantitatively scored using the American Heart Association (AHA) 17-segment LV model and a five-point scale. 0=normal, 1=mildly hypokinetic, 2=moderately hypokinetic, 3=severely hypokinetic, 4=akinetic, 5=dyskinetic. The improvement of LV wall motion was defined as a decrease of the wall motion score of at least 1 point score.
4 secondary outcomes
LV end-systolic volume (ml)
Time frame: 6 months and 12 months after the procedure
LV end-diastolic volume (ml)
Time frame: 6 months and 12 months after the procedure
LV ejection fraction (%)
Time frame: 6 months and 12 months after the procedure.
Procedural success
Time frame: immediately after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Background: PubMed 31433921Panza JA, Ellis AM, Al-Khalidi HR, Holly TA, Berman DS, Oh JK, Pohost GM, Sopko G, Chrzanowski L, Mark DB, Kukulski T, Favaloro LE, Maurer G, Farsky PS, Tan RS, Asch FM, Velazquez EJ, Rouleau JL, Lee KL, Bonow RO. Myocardial Viability and Long-Term Outcomes in Ischemic Cardiomyopathy. N Engl J Med. 2019 Aug 22;381(8):739-748. doi: 10.1056/NEJMoa1807365.
- Background: PubMed 29852933Perera D, Clayton T, Petrie MC, Greenwood JP, O'Kane PD, Evans R, Sculpher M, Mcdonagh T, Gershlick A, de Belder M, Redwood S, Carr-White G, Marber M; REVIVED investigators. Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial: Percutaneous Coronary Intervention for Ischemic Cardiomyopathy. JACC Heart Fail. 2018 Jun;6(6):517-526. doi: 10.1016/j.jchf.2018.01.024.
- Background: PubMed 36219116Wang L, Wang Y, Wang J, Xiao M, Xi XY, Chen BX, Su Y, Zhang Y, Xie B, Dong Z, Zhao S, Yang MF. Myocardial Activity at 18F-FAPI PET/CT and Risk for Sudden Cardiac Death in Hypertrophic Cardiomyopathy. Radiology. 2023 Feb;306(2):e221052. doi: 10.1148/radiol.221052. Epub 2022 Oct 11.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
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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.
Lin Zhao, Ph.D MD principal investigator
Beijing Chaoyang Hospital, Capital Medical University, Beijing, China
2 sites 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 (CTO), run by Lin Zhao at 2 sites 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 4 inclusion and 5 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Shengwen Yang, Ph.D, MD (+8617801014018 ext. +8601085231480, verayang1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of left ventricular (LV) wall motion (time frame: 6 months after the procedure). 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 NCT06655922, which also lists 3 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 24 Oct 2024.