ClinicalTrials.gg
RecruitingNCT06794684PRACTICEUpdated Jan 27, 2025

PRogression of Atheroma Evaluated by CT Angiography and IntraCoronary Imaging tEchniques

An observational study in Coronary Arterial Disease (CAD) and Coronary Arteriosclerosis, sponsored by Ruijin Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Ruijin Hospital · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 10 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 15 studies in Coronary Artery Disease by Ruijin Hospital — 10 open to participants now, 11 under way, none of them phase 3. Coronary Artery Disease · Ruijin Hospital.

Planned enrollment
Largest of 12
50,000 · median 460
Started
2016
the only one that year
Observational
12 of 15
9 open now
Primary completion
2027-05
later than 8 of 10 live
Registered
10th of 15
by date

Among the 15 studies in Coronary Artery Disease by Ruijin Hospital, this one has the largest planned enrollment of the 12 observational ones that give a count, is the only one that started in 2016, is one of 12 observational ones, reaches primary completion later than 8 of the 10 other live ones, and was the 10th registered.

Coronary Artery Disease

4,862 studies on the registry are indexed under Coronary Artery Disease; 893 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

10 of the 15 studies in Coronary Artery Disease by Ruijin Hospital are open now, in 1 country. Recruiting first, the newest first:

4 more — sign in →

By country, each count listing its studies:

All 10 open studies →

Where they have run

Who these studies take

Of the 589 Coronary Artery Disease studies recruiting now, 403 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 48 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies in Coronary Artery Disease by Ruijin Hospital, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Coronary Arterial Disease (CAD)
  • Coronary Arteriosclerosis

Keywords

  • Coronary CTA
  • Plaque Progression
  • coronary artery disease
  • high-risk plaques
  • plaque composition
  • intracoronary imaging
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • angina pectoris, or suspected CAD
  • Receive coronary CTA scan, with a visible plaque (defined as ≥25% diameter stenosis) in major coronary arteries.

Exclusion criteria

Exclusion Criteria:

  • 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 [ALT] level exceeding 3 times the ) or abnormal kidney function ( ≤30 ml/min)
  • Familial hypercholesterolemia
  • 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 24 months

Secondary outcomes

  1. Major cardiovascular events (MACEs)

    A composite endpoint of cardiovascular death, non-fatal myocardial infarction, and unplanned revascularization during follow-up

    Time frame: 5 years

  2. Cardiovascular death

    The occurrence of cardiovascular death during follow-up

    Time frame: 5 years

  3. Myocardial infarction

    The occurrence of myocardial infarction during follow-up

    Time frame: 5 years

  4. Unplanned revascularization

    The occurrence of unplanned revascularization during follow-up

    Time frame: 5 years

  5. 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

    Time frame: 24 months

  6. 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

    Time frame: 24 months

  7. 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

    Time frame: 24 months

  8. 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

    Time frame: 24 months

  9. 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

    Time frame: 24 months

  10. 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.

    Time frame: 24 months

  11. 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

    Time frame: 24 months

  12. 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

    Time frame: 24 months

  13. 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

    Time frame: 24 months

07

Study locations

2 of 2 sites recruiting
  • CAAC East China Aviation Personnel Medical Appraisal Center, Civil Aviation Shanghai Hospital
    Shanghai, 200000, China
    Recruiting
    • Lin Zhang, M.D. · Contact1002596177@qq.com · +86 21 62758030
    • Lin Zhang, M.D. · Principal investigator
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, 200025, China
    Recruiting
    • Xiaoqun Wang, M.D., Ph.D. · Contactxiaoqun_wang@hotmail.com · +86 21 64370045 671605
    • Shuo Feng, M.D., Ph.D. · Contactfengshuorv@hotmail.com · +86 21 64370045 671603
    • Xiaoqun Wang, M.D., Ph.D. · Principal investigator
    • Shuo Feng, M.D., Ph.D. · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2016 (actual). Primary completion is estimated for May 2027, 136 months after the start.

Of 636 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 136 months is above that.

Counting every sponsor, half of 761 studies reached it within 41 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 14, 2025
First posted
Jan 27, 2025
StartActual
Jan 1, 2016
Primary completionEst.
May 31, 2027
CompletionEst.
May 31, 2030
Last update
Jan 27, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06794684
Lead sponsor
Ruijin Hospital
Responsible party
RUIYAN ZHANG (Professor, Ruijin Hospital) — Principal investigator
First posted
Jan 27, 2025
Start date
Jan 1, 2016
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2030 (estimated)
Last update
Jan 27, 2025

Study contacts

Xiaoqun Wang
Contact
wangxq@shsmu.edu.cn
+86 21 64370045 671605
Shuo Feng
Contact
fengshuorv@hotmail.com
+86 21 64370045 671603
Ruiyan Zhang, M.D., Ph.D.
principal investigator · Ruijin Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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