Clinical trial NCT06702748: Prognostic Values of Coronary Microvascular Dysfunction Patients Treated with Rotational Atherectomy During Percutaneous Coronary Intervention
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Arterial Disease (CAD)
Coronary Microvascular Dysfunction (CMD)
Keywords: Coronary Microvascular Dysfunction
Index of Microcirculatory Resistance
Coronary artery disease
rotational atherectomy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older who had severe coronary calcification and underwent successful RA during PCI

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.

Eligibility criteria: 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

Primary outcomes:
measure: major adverse cardiac events
timeFrame: 24 months after PCI
Secondary outcomes:
measure: target vessel failure
timeFrame: 24 months after PCI
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 88 Jiefang Road
state: Zhejiang
Study officials:
References: