Unstable Angina (UA)NCT06868225
Scientific Rationale and Design for a Prospective Study to Codify Coronary Lesions Based on Fluid Mechanics and Acoustic Mechanisms
An observational study of Unstable Angina (UA), run by Tan Tao University, School of Medicine.
Trial summary
From January 2020 to June 2025, patients coming to the cardiac catheterization laboratories (CCL) for out-patient coronary angiography with diagnosis of unstable angina were screened for inclusion. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Unstable Angina (UA)
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2025to 30 Aug 2025
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all patients without prior PCI nor CABG
Inclusion Criteria: Patients were included in the study if they had one or two lesions in coronary angiograms. -
Exclusion Criteria: Patients with history of prior percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG) were excluded.
-
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Study to Codify Coronary Lesions Based on Fluid Mechanics and Acoustic Mechanisms
From January 2020 to June 2025, patients coming to the cardiac catheterization laboratories (CCL) for out-patient coronary angiography with diagnosis of unstable angina were screened for inclusion. Patients were included in the study if they had previously undergone one or more coronary angiograms, allowing for a longitudinal comparison of dynamic flow and phenomena between the two or more angiograms.
Read the detailed description
Patients with history of prior percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG) were excluded. The aortic stenosis patients were also excluded if they had end-stage disease with survival time <6 months or if they had other severe hemodynamic disturbances such as hypotension from non-cardiac problems (sepsis, bleeding, etc).
- Conditions
- Unstable Angina (UA)
- Medical subject headings
- Angina, Unstable
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 |
|---|---|---|
| patients coming to the cardiac catheterization laboratories for coronary angiogram | patients coming to the cardiac catheterization laboratories (CCL) for out-patient coronary angiography with diagnosis of unstable angina were screened for inclusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New lesion
If having new lesion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start20 Apr 2025 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Angina (UA)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
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tan Tao University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thach Nguyen, Tan Tao University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868225
- Sponsor's protocol ID
- TTU.RS.25.302.001
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will provide infos if needed
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Codify Coronary Lesions Based on Fluid Mechanics and Acoustic Mechanisms
- ClinicalTrials.gov ID
- NCT06868225
- Acronym / sponsor ID
- TTU.RS.25.302.001
- Conditions
- Unstable Angina (UA)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tan Tao University, School of MedicineUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 10 Mar 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.
From January 2020 to June 2025, patients coming to the cardiac catheterization laboratories (CCL) for out-patient coronary angiography with diagnosis of unstable angina were screened for inclusion. Patients were included in the study if they had previously undergone one or more coronary angiograms, allowing for a longitudinal comparison of dynamic flow and phenomena between the two or more angiograms.
Detailed description
Patients with history of prior percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG) were excluded. The aortic stenosis patients were also excluded if they had end-stage disease with survival time <6 months or if they had other severe hemodynamic disturbances such as hypotension from non-cardiac problems (sepsis, bleeding, etc).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients coming to the cardiac catheterization laboratories for coronary angiogram | – | –patients coming to the cardiac catheterization laboratories (CCL) for out-patient coronary angiography with diagnosis of unstable angina were screened for inclusion. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients without prior PCI nor CABG
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
New lesion
Time frame: 3 months
If having new lesion
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 17 Apr 2025.
- Individual participant dataSharing planned: Undecided. Will provide infos if needed
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Unstable Angina (UA), run by Tan Tao University, School of Medicine.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Apr 2025. 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?
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 Thach N Nguyen, MD (19492326331, thachnguyen2000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New lesion (time frame: 3 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 17 Apr 2025.