Scientific Rationale and Design for a Prospective Study to Codify Coronary Lesions Based on Fluid Mechanics and Acoustic Mechanisms

April 14, 2025 updated by: Thach Nguyen, Tan Tao University, School of Medicine

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

all patients without prior PCI nor CABG

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New lesion
Time Frame: 3 months
If having new lesion
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tao University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2025

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTU.RS.25.302.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Will provide infos if needed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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