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The Impact of Hyperemic State on the Performance of Angiography Derived Indices in Assessing Coronary Microvascular Disease

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The goal of this observational study is to evaluate the diagnostic performance of angiography-derived microcirculatory indices (Angio-IMR) in assessing patients with stable angina or suspected coronary artery disease. The main questions it aims to answer are: How do the numerical values of Angio-IMR from five different software vendors change across three physiological states (resting, sub-hyperemia induced by nitroglycerin, and maximal hyperemia induced by adenosine)? Which physiological state and software algorithm provide the highest diagnostic accuracy (Area Under the Curve, AUC) for diagnosing Coronary Microvascular Disease (CMD) when compared to the gold standard wire-based IMR? Researchers will compare the Angio-IMR results calculated under the three different physiological conditions within the same patient to see how the hyperemic state impacts the performance and consistency of these non-invasive indices. Participants will: Undergo standard-of-care coronary angiography and physiological assessment using a pressure wire for index of microvascular resistance (Wire-IMR) as part of their clinical management. Have their angiographic images captured at three specific time points: at rest, after intracoronary nitroglycerin, and during adenosine-induced maximal hyperemia. Allow their de-identified imaging and clinical data to be analyzed by an independent core laboratory using five different Angio-IMR software platforms to evaluate microvascular function.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Stable angina or suspected coronary heart disease.

• Scheduled for coronary angiography and physiological assessment.

• Target vessel with stenosis \< 50% or 50%-90% with fractional flow reserve (FFR) \> 0.80.

• Provided informed consent.

Locations
Other Locations
China
The First Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Chenguang Li, MD, PhD
li.chenguang@zs-hospital.sh.cn
021 6404 1990
Backup
Jinying Zhou, MD, PhD
zhou.jinying@zs-hospital.sh.cn
Time Frame
Start Date: 2026-05-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 192
Treatments
Single cohort, self-controlled
Sponsors
Leads: Shanghai Zhongshan Hospital
Collaborators: Zhongnan Hospital, First Affiliated Hospital, Sun Yat-Sen University, The 7th People's Hospital of Zhengzhou

This content was sourced from clinicaltrials.gov