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RecruitingNCT04691037CICM-SCPUpdated Mar 28, 2024

CCTA Improves Clinical Management of Stable Chest Pain

An observational study in Coronary Computed Tomography Angiography, Stable Chest Pain and Optimal Medical Therapy, sponsored by Tianjin Chest Hospital. Recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by Tianjin Chest Hospital · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50,000
Ages
18 Years and older
Sex
All
01

Study summary

The investigator aims to prospectively enroll patients who were referred for coronary computed tomography angiography (CCTA) for the assessment of stable chest pain (SCP) suspected of obstructive coronary artery disease (CAD). All patients underwent CCTA according to established guidelines and local institutional protocols. The imaging data were evaluated using different image post-processing software to comprehensively analyse anatomical, functional and histological information of coronary. This study will determine if CCTA-based imaging evaluation can provide more informaton to improve clinical management for SCP, including fewer MACE and better decision-making of downstream investigations and therapeutic interventions.

02

Conditions studied

  • Coronary Computed Tomography Angiography
  • Stable Chest Pain
  • Optimal Medical Therapy
  • Invasive Coronary Angiography
  • Revascularization
  • Major Adverse Cardiovascular Events
  • Coronary Artery Disease
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 50,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Tianjin Chest Hospital is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who were referred for CCTA for the assessment of SCP suspected of CAD.

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

  • symptomatic patients with SCP suspected of obstructive CAD.
  • referred for CCTA for the assessment of SCP.
  • ≥18 years of age.
  • signed .

Exclusion criteria

Exclusion Criteria:

  • acute coronary syndromes
  • previous CAD or coronary revascularization
  • nonsinus rhythm
  • cardiomyopathy, valvular disease, congenital heart disease or left cardiac insufficiency because of other reasons
Terms in these criteria, in plain language(1)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • CCTA

    Diagnostic Test: CCTA

Interventions

  • Diagnostic testCCTA

    All patients underwent CCTA according to established guidelines and local institutional protocols. The imaging data were evaluated using different image post-processing software to comprehensively analyse anatomical, functional and histological information of coronary.

06

What researchers measure

Primary outcomes

  1. Major adverse cardiovascular events

    Cardiac death and myocardial infarction

    Time frame: 10 years

Secondary outcomes

  1. Invasive coronary angiography

    Invasive coronary angiography occurred at follow-up after CCTA, attributed to CCTA results or unplanned.

    Time frame: 10 years

  2. Medication prescription

    Change for medication prescription of antiplatelet agents, anti-ischemic drugs, lipid-lowering agents, angiotensin-converting enzyme inhibition and so on, attributed to CCTA results or unplanned,

    Time frame: 10 years

  3. Coronary revascularization

    PTCA, PCI or CABG occurred at follow-up after CCTA, attributed to CCTA results or unplanned.

    Time frame: 10 years

  4. Number of Participants with Death

    Time frame: 10 years

  5. Number of Participants with Stroke

    Time frame: 3 years

  6. Number of Participants with Cardiac death

    Time frame: 10 years

  7. Number of Participants with Myocardial infarction

    Time frame: 10 years

07

Study locations

4 of 4 sites recruiting
08

References and documents

Publications

  • Jiang H, Feng J, Feng C, Ren P, Ren K, Jin Y, Zhou J. Validation and Comparison of PROMISE and CONFIRM Model to Predict High-Risk Coronary Artery Disease in Symptomatic and Diabetes Mellitus Patients. Rev Cardiovasc Med. 2022 Mar 1;23(3):80. doi: 10.31083/j.rcm2303080. PubMed 35345247 ↗

Individual participant data

Plan to share: No

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 Jan 2030, 168 months after the start.

Of 634 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 168 months is above that.

Counting every sponsor, half of 759 studies reached it within 40 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
Dec 29, 2020
First posted
Dec 31, 2020
StartActual
Jan 1, 2016
Primary completionEst.
Jan 1, 2030
CompletionEst.
Jan 1, 2030
Last update
Mar 28, 2024
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 Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04691037
Lead sponsor
Tianjin Chest Hospital
Responsible party
Zhou Jia (Doctor, Tianjin Chest Hospital) — Principal investigator
First posted
Dec 31, 2020
Start date
Jan 1, 2016
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Mar 28, 2024

Study contacts

Jia Zhou
Contact
zhoujiawenzhang@126.com
+8615522485560

Oversight

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

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