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Impact of Rotational Atherectomy on Coronary Microcirculation (MICRO-ROTA)

Primary Purpose

Stable Angina, Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
coronary pressure/temperature sensor-tipped guidewire
Angiography-derived index of microcirculatory resistance (IMRangio)
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring Rotational atherectomy, Conventional stenting, CMD, Microcirculation, Index of microcirculatory resistance, IMRangio

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient diagnosed with stable coronary artery calcified lesion requiring Percutaneous coronary intervention Exclusion Criteria: patients with a history of old myocardial infarction or history of coronary artery bypass grafting (CABG) or Percutaneous coronary intervention PCI Patients with signs of chronic infection, prolong usage of corticosteroids or compromised immune system patients had contraindication of adenosine triphosphate (ATP); had a history of liver or renal function dysfunction Patients with dementia Patients being referred to CABG unable to provide informed consent; had pregnancy or life span < 1 year. Presence of sever structural valvular heart disease Presence of significant left main disease Unability to measure the index of microcirculatory resistance due to (death or retraction from the study ...etc) Inability to perform successful PCI

Sites / Locations

  • Lithuanian University of Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rotational Atherectomy

Conventional Stenting

Arm Description

Patients who are scheduled to have rotational atherectomy will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the rotational atherectomy procedure.

Patients who are scheduled to have conventional stenting will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the conventional stenting procedure.

Outcomes

Primary Outcome Measures

The incidence of coronary microvascular dysfunction
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value < 2.5 U or angio IMR ≥ 25 U

Secondary Outcome Measures

Rate of Major adverse cardiovascular events
composite of nonfatal stroke, nonfatal myocardial infarction, heart failure, target vessel revascularization and cardiovascular death.
The incidence of coronary microvascular dysfunction
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value < 2.5 U or angio IMR ≥ 25 U
Seattle Angina Questionnaire score
Evaluates the severity of angina symptoms, physical limitations, and quality of life

Full Information

First Posted
March 5, 2023
Last Updated
March 15, 2023
Sponsor
Lithuanian University of Health Sciences
Collaborators
Klaipėda University, Kreiskrankenhaus Rotenburg an der fluda, Alkafeel Super Speciality Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05771961
Brief Title
Impact of Rotational Atherectomy on Coronary Microcirculation
Acronym
MICRO-ROTA
Official Title
Impact of Rotational Atherectomy on Coronary Microvascular Function in Patients With Stable Angina and Calcified Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
Collaborators
Klaipėda University, Kreiskrankenhaus Rotenburg an der fluda, Alkafeel Super Speciality Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this observational study is to compare the impact of rotational atherectomy to conventional stenting and to investigate how it may affect coronary microcirculation in patients with calcified coronary artery lesions and stable CAD. The study's objectives are to: investigate the impact of rotational atherectomy on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction; investigate the impact of conventional stenting on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction; and compare the impact of both percutaneuos coronary interventions on coronary microvascular dysfunction. Patients with calcified lesions will be enrolled prospectively and will have serial invasive and non-invasive microvascular testing prior to and after rotational atherectomy or conventional stenting.
Detailed Description
Rotational atherectomy (RA) is a medical procedure used to treat patients with severe atherosclerosis, a condition that causes plaque buildup within the artery walls, resulting in narrowing of the blood vessels and decreased blood flow to the heart. RA is a technique that involves breaking up and removing plaque from the artery with a small, high-speed rotating burr. However, RA is not without risks. One of the major risks associated with RA is the potential damage to the artery wall and surrounding tissue. This can lead to complications such as bleeding, blood clots, or injury to the heart or other organs. Additionally, the high-speed rotation of the burr can generate heat, which may damage the artery wall or cause the release of harmful particles into the bloodstream. Another hypothesized risk of RA is its impact on microcirculation, which refers to the smallest blood vessels in the body. RA can cause disruption to these vessels, leading to a decrease in blood flow and potentially causing damage to tissues and organs that depend on them. The purpose of this study is to look into the effect of rotational atherectomy on coronary microcirculation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina, Coronary Artery Disease
Keywords
Rotational atherectomy, Conventional stenting, CMD, Microcirculation, Index of microcirculatory resistance, IMRangio

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to receive either the rotational atherectomy or conventional stenting alone.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rotational Atherectomy
Arm Type
Active Comparator
Arm Description
Patients who are scheduled to have rotational atherectomy will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the rotational atherectomy procedure.
Arm Title
Conventional Stenting
Arm Type
Active Comparator
Arm Description
Patients who are scheduled to have conventional stenting will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the conventional stenting procedure.
Intervention Type
Diagnostic Test
Intervention Name(s)
coronary pressure/temperature sensor-tipped guidewire
Intervention Description
In brief, a 6-F angioplasty guiding catheter without side-holes will be used first used to engage the left main coronary artery. A pressure-temperature sensor guidewire ( PressureWire™ X Guidewire) will be used for physiology measurements including IMR measurements. Pressure measurement from the wire will be first equalized with that of the guiding catheter. Then the pressure sensor will be positioned two-thirds of the way down the LAD artery. Intracoronary nitroglycerin will be administered (100 to 200 μg). Hyperemia will be induced with adenosine intracoronary injections.
Intervention Type
Diagnostic Test
Intervention Name(s)
Angiography-derived index of microcirculatory resistance (IMRangio)
Intervention Description
Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software
Primary Outcome Measure Information:
Title
The incidence of coronary microvascular dysfunction
Description
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value < 2.5 U or angio IMR ≥ 25 U
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Rate of Major adverse cardiovascular events
Description
composite of nonfatal stroke, nonfatal myocardial infarction, heart failure, target vessel revascularization and cardiovascular death.
Time Frame
1 year
Title
The incidence of coronary microvascular dysfunction
Description
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value < 2.5 U or angio IMR ≥ 25 U
Time Frame
1 year
Title
Seattle Angina Questionnaire score
Description
Evaluates the severity of angina symptoms, physical limitations, and quality of life
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient diagnosed with stable coronary artery calcified lesion requiring Percutaneous coronary intervention Exclusion Criteria: patients with a history of old myocardial infarction or history of coronary artery bypass grafting (CABG) or Percutaneous coronary intervention PCI Patients with signs of chronic infection, prolong usage of corticosteroids or compromised immune system patients had contraindication of adenosine triphosphate (ATP); had a history of liver or renal function dysfunction Patients with dementia Patients being referred to CABG unable to provide informed consent; had pregnancy or life span < 1 year. Presence of sever structural valvular heart disease Presence of significant left main disease Unability to measure the index of microcirculatory resistance due to (death or retraction from the study ...etc) Inability to perform successful PCI
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Aldujeli
Phone
+37064874874
Email
ali.aldujeli@kaunoklinikos.lt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Aldujeli
Organizational Affiliation
Lithuanian University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lithuanian University of Health Sciences
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Aldujeli
Phone
864874874
Email
ali.aldujeli@kaunoklinikos.lt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Impact of Rotational Atherectomy on Coronary Microcirculation

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