Angiography-Derived Physiological Indices for Outcome Prediction in Patients Undergoing OCT-Guided PCI

ConditionCoronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-84

SponsorBeijing Anzhen Hospital

About this trial

The primary design of this study is an ambispective observational cohort study. In patients undergoing successful optical coherence tomography (OCT)-guided percutaneous coronary intervention (PCI) with post-procedural angiographic images suitable for computational analysis, this study aims to evaluate the prognostic value of post-PCI angiography-derived physiological indices, specifically angiography-derived fractional flow reserve (Angio-FFR) and angiography-derived index of microcirculatory resistance (Angio-IMR), beyond conventional clinical risk factors and OCT-derived anatomical parameters. Specifically, the objectives are:

1. To determine the associations of post-PCI Angio-FFR and Angio-IMR with the risk of Major Adverse Cardiovascular Events (MACE) during follow-up. 2. To evaluate the incremental prognostic value of post-PCI Angio-FFR and Angio-IMR when added to models incorporating baseline clinical characteristics and OCT-derived anatomical parameters for predicting MACE. 3. To assess whether the combined evaluation of Angio-FFR and Angio-IMR improves identification of residual risk after anatomically optimized, OCT-guided PCI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adult patients with coronary artery disease undergoing successful OCT-guided PCI with stent implantation at participating centers in China, with post-procedural angiographic images suitable for computation of pre-PPG and post-Angio-FFR and post- Angio-IMR.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

OCT-guided PCI
Procedure/Surgery
Not applicable as assigned study interventions. This is an observational study. OCT-guided PCI will be performed according to routine clinical practice at each participating center. Coronary angiographic images obtained before and after PCI will be used to derive angiography-based physiologic indices, including pre-PCI pullback pressure gradient (PPG) and post-PCI Angio-FFR and Angio-IMR, for physiologic characterization and outcome analysis.

Treatment groups

1,800 Participants

are divided into 2 treatment groups

Group A: Retrospective cohort1 intervention

Group B: Prospective cohort1 intervention

Trial outcomes

Primary outcomes

Major Adverse Cardiovascular Events

MACE is defined as the first occurrence of any of the following events: all-cause death, spontaneous target-vessel myocardial infarction, ischemia-driven target-vessel revascularization, hospitalization for unstable angina, or hospitalization for heart failure.

Time frame