Coronary Arterial Disease (CAD)PRACTICENCT06794684
PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques
An observational study of Coronary Arterial Disease (CAD) and Coronary Arteriosclerosis, run by Ruijin Hospital at 2 sites in China.
Trial summary
This is a combined cohort study with retrospectively and prospectively enrolled coronary artery disease (CAD) patients. All the patients will undergo clinical follow-up for up to 5 years, and repeat coronary CTA will be conducted after 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Coronary Arteriosclerosis
- How many people
- 50,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2016to 31 May 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This is a combination of retrospective and prospective cohort studies. Patients with clinical angina pectoris or suspected CAD who undergo coronary CTA scan, including outpatient and hospitalized patients, are consecutively enrolled.
Who may be able to join
- Age ≥ 18 years
- Clinically significant angina pectoris, or suspected CAD
- Receive coronary CTA scan, with a visible plaque (defined as ≥25% diameter stenosis) in major coronary arteries.
Who cannot join
- Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
- Receive percutaneous coronary intervention (PCI) within 6 months
- Prior history of myocardial infarction or heart failure
- Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- Abnormal liver function (serum alanine aminotransferase [ALT] level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR ≤30 ml/min)
- Familial hypercholesterolemia
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- Estimated survival ≤ 1 year
- Malignant tumor
- Pregnant or lactation, or have the intention to give birth within one year
- Poor coordinance, unable to follow-up
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital
Shanghai, 200000
Lin Zhang, M.D., +86 21 62758030, 1002596177@qq.com
Lin Zhang, M.D.
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Xiaoqun Wang, M.D., Ph.D., +86 21 64370045 671605, xiaoqun_wang@hotmail.com
Shuo Feng, M.D., Ph.D., +86 21 64370045 671603, fengshuorv@hotmail.com
About this study
Official title: Evaluation of Atherosclerotic Plaque Progression by Coronary Computed Tomography Angiography and Intracoronary Imaging Techniques in Patients With Coronary Artery Disease
This is a combined cohort study with retrospectively and prospectively enrolled coronary artery disease (CAD) patients. All the patients will undergo clinical follow-up for up to 5 years, and repeat coronary CTA will be conducted after 2 years. Comprehensive morphological and functional plaque analysis will be performed. The impact of these morphological and functional parameters, alongside cardiometabolic factors and pharmacological treatments on plaque progression and the occurrence of major adverse cardiovascular events (MACEs) will be analyzed. In addition, intracoronary imaging techniques will be used to improve the accuracy of plaque analysis by coronary CTA.
Read the detailed description
This is a combined cohort study with retrospectively and prospectively enrolled patients. Subjects with CAD detected by coronary CTA are consecutively enrolled. All the patients will undergo clinical follow-up for up to 5 years. Repeat coronary CTA will be conducted after 2 years. For patients referred to invasive coronary angiography, intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS) will be performed. For all the prospectively enrolled patients, plasma and serum blood samples will be collected.
The purpose of this study is to investigate the natural history of coronary atherosclerotic plaques in this population. Comprehensive morphological plaque analysis will be performed to evaluate total atheroma volume (TAV), percent atheroma volume (PAV), plaque composition, high risk plaque features, and characteristics of perivascular adipose tissue (PVAT). Functional analysis will also be conducted to calculate hemodynamic parameters such as wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RTT), transverse WSS (transWSS), axis plaque stress (APS), fractional flow reserve (FFR), and δFFR across lesions. The associations of these morphological and functional parameters with plaque progression and the onset of major adverse cardiovascular events (MACEs) will be analyzed. In addition, the impact of pharmacological treatments and the levels of cardiometabolic factors on coronary plaque progression will also be investigated.
In the subpopulation who also receive intracoronary imaging examinations, intracoronary imaging modalities will be used to refine the inner and outer vessel contours, improve the accuracy of plaque composition characterization, and aid in the discovery of novel high-risk plaque features by coronary CTA.
- Keywords
- Coronary CTA, Plaque Progression, coronary artery disease, high-risk plaques, plaque composition, intracoronary imaging
- 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.
| Study group | Role | What they receive |
|---|---|---|
| PRACTICE cohort | Subjects with CAD detected by coronary CTA are consecutively enrolled. All the patients will undergo clinical follow-up for up to 5 years. Repeat coronary CTA will be conducted after 2 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total atheroma volume (TAV)
changes in TAV in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Measured: 24 months
Secondary outcomes (13)
Major cardiovascular events (MACEs)
A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up
Measured: 5 years
Cardiovascular death
The occurrence of cardiovascular death during follow-up
Measured: 5 years
Myocardial infarction
The occurrence of myocardial infarction during follow-up
Measured: 5 years
Unplanned revascularization
The occurrence of unplanned revascularization during follow-up
Measured: 5 years
Changes in calcified plaque volume
Changes in calcified plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Measured: 24 months
Changes in non-calcified plaque volume
Changes in non-calcified plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Measured: 24 months
Changes in fibrous plaque volume
Changes in fibrous plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Measured: 24 months
Changes in fibrousfatty plaque volume
Changes in fibrousfatty plaque volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Measured: 24 months
Changes in necrotic core volume
Changes in plaque necrotic core volume in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
Measured: 24 months
Changes in high-risk plaque (HRP) features
Changes in the number of HRP features in whole heart and in target lesions measured by coronary CTA at baseline and during follow-up.
Measured: 24 months
Changes in perivascular adipose tissue (PVAT) volume
Changes in the volume of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
Measured: 24 months
Changes in perivascular adipose tissue (PVAT) density
Changes in the density of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
Measured: 24 months
Changes in perivascular adipose tissue (PVAT) distribution
Changes in the distribution of PVAT measured by coronary CTA and quantification analysis at baseline and during follow-up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Jan 2016
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 50,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUIYAN ZHANG, Ruijin Hospital
- Investigators
- Ruiyan Zhang, M.D., Ph.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794684
- Sponsor's protocol ID
- RJH-PRACTICE
- Acronym
- PRACTICE
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Atherosclerotic Plaque Progression by Coronary Computed Tomography Angiography and Intracoronary Imaging Techniques in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06794684
- Acronym / sponsor ID
- PRACTICE / RJH-PRACTICE
- Keywords
- Coronary CTA, Plaque Progression, coronary artery disease, high-risk plaques, plaque composition, intracoronary imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 27 Jan 2025 (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 is a combined cohort study with retrospectively and prospectively enrolled coronary artery disease (CAD) patients. All the patients will undergo clinical follow-up for up to 5 years, and repeat coronary CTA will be conducted after 2 years. Comprehensive morphological and functional plaque analysis will be performed. The impact of these morphological and functional parameters, alongside cardiometabolic factors and pharmacological treatments on plaque progression and the occurrence of major adverse cardiovascular events (MACEs) will be analyzed. In addition, intracoronary imaging techniques will be used to improve the accuracy of plaque analysis by coronary CTA.
Detailed description
This is a combined cohort study with retrospectively and prospectively enrolled patients. Subjects with CAD detected by coronary CTA are consecutively enrolled. All the patients will undergo clinical follow-up for up to 5 years. Repeat coronary CTA will be conducted after 2 years. For patients referred to invasive coronary angiography, intracoronary imaging techniques, such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and near infrared spectroscopy (NIRS) will be performed. For all the prospectively enrolled patients, plasma and serum blood samples will be collected.
The purpose of this study is to investigate the natural history of coronary atherosclerotic plaques in this population. Comprehensive morphological plaque analysis will be performed to evaluate total atheroma volume (TAV), percent atheroma volume (PAV), plaque composition, high risk plaque features, and characteristics of perivascular adipose tissue (PVAT). Functional analysis will also be conducted to calculate hemodynamic parameters such as wall shear stress (WSS), oscillatory shear index (OSI), relative residence time (RTT), transverse WSS (transWSS), axis plaque stress (APS), fractional flow reserve (FFR), and δFFR across lesions. The associations of these morphological and functional parameters with plaque progression and the onset of major adverse cardiovascular events (MACEs) will be analyzed. In addition, the impact of pharmacological treatments and the levels of cardiometabolic factors on coronary plaque progression will also be investigated.
In the subpopulation who also receive intracoronary imaging examinations, intracoronary imaging modalities will be used to refine the inner and outer vessel contours, improve the accuracy of plaque composition characterization, and aid in the discovery of novel high-risk plaque features by coronary CTA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRACTICE cohort | – | –Subjects with CAD detected by coronary CTA are consecutively enrolled. All the patients will undergo clinical follow-up for up to 5 years. Repeat coronary CTA will be conducted after 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a combination of retrospective and prospective cohort studies. Patients with clinical angina pectoris or suspected CAD who undergo coronary CTA scan, including outpatient and hospitalized patients, are consecutively enrolled.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Clinically significant angina pectoris, or suspected CAD
- Receive coronary CTA scan, with a visible plaque (defined as ≥25% diameter stenosis) in major coronary arteries.
Key exclusion criteria (10 listed)
- Unsuitable for coronary CTA (such as severe renal impairment, uncontrolled thyroid condition, allergic to iodine, etc.)
- Receive percutaneous coronary intervention (PCI) within 6 months
- Prior history of myocardial infarction or heart failure
- Prior history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- Abnormal liver function (serum alanine aminotransferase [ALT] level exceeding 3 times the upper limit of normal) or abnormal kidney function (eGFR ≤30 ml/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in total atheroma volume (TAV)
Time frame: 24 months
changes in TAV in whole heart and in target lesions measured by coronary CTA and quantification analysis at baseline and during follow-up
13 secondary outcomes
Major cardiovascular events (MACEs)
Time frame: 5 years
Cardiovascular death
Time frame: 5 years
Myocardial infarction
Time frame: 5 years
Unplanned revascularization
Time frame: 5 years
Changes in calcified plaque volume
Time frame: 24 months
Changes in non-calcified plaque volume
Time frame: 24 months
Changes in fibrous plaque volume
Time frame: 24 months
Changes in fibrousfatty plaque volume
Time frame: 24 months
Changes in necrotic core volume
Time frame: 24 months
Changes in high-risk plaque (HRP) features
Time frame: 24 months
Changes in perivascular adipose tissue (PVAT) volume
Time frame: 24 months
Changes in perivascular adipose tissue (PVAT) density
Time frame: 24 months
Changes in perivascular adipose tissue (PVAT) distribution
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- 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.
Ruiyan Zhang, M.D., Ph.D. principal investigator
Ruijin Hospital
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 Coronary Arterial Disease (CAD) and Coronary Arteriosclerosis, run by Ruijin Hospital 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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoqun Wang (+86 21 64370045 671605, wangxq@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total atheroma volume (TAV) (time frame: 24 months). 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 27 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.