Coronary Artery DiseaseCHART-ORIGINNCT05104580
PrOgnostic Implications of PRe-stent Pullback Pressure GradIent and Post-stent Quantitative Flow Ratio in Patients UnderGoing Percutaneous Coronary INtervention
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital.
Trial summary
The purpose of this study is to investigate the prognostic implication of pre-percutaneous coronary intervention (PCI) focal or diffuse disease patterns combined with post-PCI quantitative flow ratio (QFR). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Quantitative Flow Ratio derived PPG
- Type of treatment
- Medical device
- How many people
- 1,395 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2021to 1 Mar 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1,395 patients with 1,685 target vessels with measurable QFR and PPG index from the PANDA-III study (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice) (NCT02017275).
Who may be able to join
- Patients with at least one vessel with measurable QFR
- PPG index can be calculated from virtual QFR pullback curve;
- The patient is willing to comply with specified follow-up evaluations;
- Patients who agree to accept the follow-up visits.
Who cannot join
- Culprit vessels for ACS myocardial infarction;
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
- Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
- Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
- Currently participating in another investigational drug or device study or patient in inclusion in another investigational drug or device study during follow-up.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study is to investigate the prognostic implication of pre-percutaneous coronary intervention (PCI) focal or diffuse disease patterns combined with post-PCI quantitative flow ratio (QFR).
Read the detailed description
Coronary diffuse disease associates with poor outcomes, but little is known about whether this prognostic value retains after PCI, especially in those with good post-PCI physiologic results.
QFR can provide the virtual pullback curve by depicting pressure at each point along the interrogated vessel, which can be used to calculate the pullback pressure gradient (PPG) index, this index has been shown to be able to suggest the physiological plaque distribution and to discriminate focal from diffuse disease. Absolute quantification of coronary diffuseness makes it possible to evaluate the prognostic value of baseline coronary diffuseness before stent implantation, which is rarely investigated till now.
The CHART-ORIGIN study aims to investigate the independent and additive prognostic implications of pre-PCI functional disease patterns assessed by PPG with post-PCI QFR in vessels with stent implantation.
- Conditions
- Coronary Artery Disease
- Being tested
- Quantitative Flow Ratio derived PPG
- 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.
Quantitative Flow Ratio derived PPGDevice
From coronary angiographic images, QFR will be calculated and virtual pullback curve will be abstracted and PPG index will be calculated as:
PPG index={MaxPPG20mm/△QFRvessel+(1-length with functional disease/Total vessel length) }/2.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | High pre-PCI PPG index and high post-PCI QFR Receives: Device: Quantitative Flow Ratio derived PPG | |
| Group 2 | Low pre-PCI PPG index and high post-PCI QFR Receives: Device: Quantitative Flow Ratio derived PPG | |
| Group 3 | Low post-PCI QFR regardless of pre-PCI PPG index Receives: Device: Quantitative Flow Ratio derived PPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel-oriented composite outcome
Vessel-oriented composite outcome (VOCO) including vessel related ischemia-driven target vessel revascularization, vessel-related myocardial infarction (MI), and cardiac death.
Measured: at 2 years from index procedure
Secondary outcomes (4)
Cardiac death or vessel-related MI
Cardiac death or vessel-related MI
Measured: at 2 years from index procedure
Vessel-related MI
Vessel-related MI
Measured: at 2 years from index procedure
Cardiac death
Cardiac death
Measured: at 2 years from index procedure
Ischemia-driven target vessel revascularization
Ischemia-driven target vessel revascularization
Measured: at 2 years from index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start30 Oct 2021 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,395 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
- Investigators
- Junbo Ge, Professor, Study chair, Fudan UniversityBo Xu, MBBS, Principal investigator, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104580
- Sponsor's protocol ID
- ZS-20211021
- Acronym
- CHART-ORIGIN
- Status last verified
- Oct 2021
- First submitted
- 21 Oct 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Xu B, Gao R, Yang Y, Cao X, Qin L, Li Y, Li Z, Li X, Lin H, Guo Y, Ma Y, Wang J, Nie S, Xu L, Cao E, Guan C, Stone GW; PANDA III Investigators. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial. J Am Coll Cardiol. 2016 May 17;67(19):2249-2258. doi: 10.1016/j.jacc.2016.03.475.
PubMed 27173037Dai N, Hwang D, Lee JM, Zhang J, Jeon KH, Paeng JC, Cheon GJ, Koo BK, Ge J. Feasibility of Quantitative Flow Ratio-Derived Pullback Pressure Gradient Index and Its Impact on Diagnostic Performance. JACC Cardiovasc Interv. 2021 Feb 8;14(3):353-355. doi: 10.1016/j.jcin.2020.10.036. No abstract available.
PubMed 33541549Dai N, Zhang R, Hu N, Guan C, Zou T, Qiao Z, Zhang M, Duan S, Xie L, Dou K, Zhang Y, Xu B, Ge J. Integrated coronary disease burden and patterns to discriminate vessels benefiting from percutaneous coronary intervention. Catheter Cardiovasc Interv. 2022 Jan 1;99(1):E12-E21. doi: 10.1002/ccd.29983. Epub 2021 Oct 15.
PubMed 34652068Dai N, Yuan S, Dou K, Zhang R, Hu N, He J, Guan C, Zou T, Qiao Z, Duan S, Xie L, Yu Y, Zhang Y, Xu B, Ge J. Prognostic Implications of Prestent Pullback Pressure Gradient and Poststent Quantitative Flow Ratio in Patients Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2022 Jun 7;11(11):e024903. doi: 10.1161/JAHA.121.024903. Epub 2022 Jun 3.
PubMed 35656982
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrOgnostic Implications of PRe-stent Pullback Pressure GradIent and Post-stent Quantitative Flow Ratio in Patients UnderGoing Percutaneous Coronary INtervention
- ClinicalTrials.gov ID
- NCT05104580
- Acronym / sponsor ID
- CHART-ORIGIN / ZS-20211021
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,395 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 30 Oct 2021 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 3 Nov 2021 (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.
The purpose of this study is to investigate the prognostic implication of pre-percutaneous coronary intervention (PCI) focal or diffuse disease patterns combined with post-PCI quantitative flow ratio (QFR).
Detailed description
Coronary diffuse disease associates with poor outcomes, but little is known about whether this prognostic value retains after PCI, especially in those with good post-PCI physiologic results.
QFR can provide the virtual pullback curve by depicting pressure at each point along the interrogated vessel, which can be used to calculate the pullback pressure gradient (PPG) index, this index has been shown to be able to suggest the physiological plaque distribution and to discriminate focal from diffuse disease. Absolute quantification of coronary diffuseness makes it possible to evaluate the prognostic value of baseline coronary diffuseness before stent implantation, which is rarely investigated till now.
The CHART-ORIGIN study aims to investigate the independent and additive prognostic implications of pre-PCI functional disease patterns assessed by PPG with post-PCI QFR in vessels with stent implantation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: Quantitative Flow Ratio derived PPGHigh pre-PCI PPG index and high post-PCI QFR |
| Group 2 | – | Device: Quantitative Flow Ratio derived PPGLow pre-PCI PPG index and high post-PCI QFR |
| Group 3 | – | Device: Quantitative Flow Ratio derived PPGLow post-PCI QFR regardless of pre-PCI PPG index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1,395 patients with 1,685 target vessels with measurable QFR and PPG index from the PANDA-III study (Comparison of BuMA eG Based BioDegradable Polymer Stent With EXCEL Biodegradable Polymer Sirolimus-eluting Stent in "Real-World" Practice) (NCT02017275).
Key inclusion criteria (4 listed)
- Patients with at least one vessel with measurable QFR
- PPG index can be calculated from virtual QFR pullback curve;
- The patient is willing to comply with specified follow-up evaluations;
- Patients who agree to accept the follow-up visits.
Key exclusion criteria (6 listed)
- Culprit vessels for ACS myocardial infarction;
- Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following index procedure;
- Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy (i.e., less than 1 year);
- Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, rapamycin, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately pre-medicated;
- Any significant medical condition which in the Investigator's opinion may interfere with the patient's optimal participation in the study;
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 |
|---|---|---|
| Quantitative Flow Ratio derived PPGFrom coronary angiographic images, QFR will be calculated and virtual pullback curve will be abstracted and PPG index will be calculated as: PPG index={MaxPPG20mm/△QFRvessel+(1-length with functional disease/Total vessel length) }/2. | Device | Group 1, Group 2, Group 3 |
Primary outcome
Vessel-oriented composite outcome
Time frame: at 2 years from index procedure
Vessel-oriented composite outcome (VOCO) including vessel related ischemia-driven target vessel revascularization, vessel-related myocardial infarction (MI), and cardiac death.
4 secondary outcomes
Cardiac death or vessel-related MI
Time frame: at 2 years from index procedure
Vessel-related MI
Time frame: at 2 years from index procedure
Cardiac death
Time frame: at 2 years from index procedure
Ischemia-driven target vessel revascularization
Time frame: at 2 years from index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2021.
- Background: PubMed 27173037Xu B, Gao R, Yang Y, Cao X, Qin L, Li Y, Li Z, Li X, Lin H, Guo Y, Ma Y, Wang J, Nie S, Xu L, Cao E, Guan C, Stone GW; PANDA III Investigators. Biodegradable Polymer-Based Sirolimus-Eluting Stents With Differing Elution and Absorption Kinetics: The PANDA III Trial. J Am Coll Cardiol. 2016 May 17;67(19):2249-2258. doi: 10.1016/j.jacc.2016.03.475.
- Background: PubMed 33541549Dai N, Hwang D, Lee JM, Zhang J, Jeon KH, Paeng JC, Cheon GJ, Koo BK, Ge J. Feasibility of Quantitative Flow Ratio-Derived Pullback Pressure Gradient Index and Its Impact on Diagnostic Performance. JACC Cardiovasc Interv. 2021 Feb 8;14(3):353-355. doi: 10.1016/j.jcin.2020.10.036. No abstract available.
- Background: PubMed 34652068Dai N, Zhang R, Hu N, Guan C, Zou T, Qiao Z, Zhang M, Duan S, Xie L, Dou K, Zhang Y, Xu B, Ge J. Integrated coronary disease burden and patterns to discriminate vessels benefiting from percutaneous coronary intervention. Catheter Cardiovasc Interv. 2022 Jan 1;99(1):E12-E21. doi: 10.1002/ccd.29983. Epub 2021 Oct 15.
- Derived from this study: PubMed 35656982Dai N, Yuan S, Dou K, Zhang R, Hu N, He J, Guan C, Zou T, Qiao Z, Duan S, Xie L, Yu Y, Zhang Y, Xu B, Ge J. Prognostic Implications of Prestent Pullback Pressure Gradient and Poststent Quantitative Flow Ratio in Patients Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2022 Jun 7;11(11):e024903. doi: 10.1161/JAHA.121.024903. Epub 2022 Jun 3.
- Individual participant dataSharing planned: Undecided
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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.
Junbo Ge, Professor study chair
Fudan University
Bo Xu, MBBS principal investigator
Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital.
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 6 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Neng Dai, MD (+8613701997266, niceday1987@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel-oriented composite outcome (time frame: at 2 years from index 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 NCT05104580, which also lists 4 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 3 Nov 2021.