Prognostic Values of Coronary Microvascular Dysfunction Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention

Research on New Technologies for the Diagnosis and Treatment of Cardiovascular Diseases-Multi-parameter Noninvasive Early Diagnosis of Coronary Microvascular Diseases Series I: Clinical Study Protocol for a New Method of Evaluating Coronary Microvessels Based on Coronary IMR Calculated from Coronary Angiography Images

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06702748

Enrollment

452

Registered

2024-11-25

Start date

2015-01-01

Completion date

2025-12-31

Last updated

2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Arterial Disease (CAD), Coronary Microvascular Dysfunction (CMD)

Keywords

Coronary Microvascular Dysfunction, Index of Microcirculatory Resistance, Coronary artery disease, rotational atherectomy

Brief summary

The goal of this observational study is to learn about the long-term prognostic of coronary microvascular dysfuction in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention. The main question it aims to answer is: Does the coronary microvascular dysfunction impact the outcomes in Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention. Participants will answer survey questions about their clinical outcomes for 2 years by telephone.

Detailed description

This study was a retrospective, multicenter observational investigation and approved by the local Human Research Ethics Committee and conducted in accordance with the principles outlined in the Helsinki Declaration.Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI were eligible for inclusion in the study. Exclusion criteria included target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification. Angiography-derived index of microcirculatory resistance was measured in the target vessel treated with RA pre-PCI and post-PCI and blinded and performed by an independent core laboratory.The follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI

Exclusion criteria

* target vessel was chronic total occlusion, poor angiographic image quality, failed RA and RA not used for severe coronary calcification

Design outcomes

Primary

Measure	Time frame	Description
major adverse cardiac events	24 months after PCI	the composite of cardiac death, myocardial reinfarction, target vessel revascularization, and readmission for unstable angina

Secondary

Measure	Time frame	Description
target vessel failure	24 months after PCI	composed of cardiac death, target vessel myocardial infarction, target vessel revascularization

Countries

China

Outcome results