Impact of Rotational Atherectomy on Coronary Microcirculation (MICRO-ROTA)
Impact of Rotational Atherectomy on Coronary Microvascular Function in Patients With Stable Angina and Calcified Coronary Artery Disease
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ali Aldujeli
- Phone Number: +37064874874
- Email: ali.aldujeli@kaunoklinikos.lt
Study Locations
-
-
-
Kaunas, Lithuania, LT-50161
- Recruiting
- Lithuanian University of Health Sciences
-
Contact:
- Ali Aldujeli
- Phone Number: 864874874
- Email: ali.aldujeli@kaunoklinikos.lt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Rotational Atherectomy
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.
|
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.
Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software
|
|
Active Comparator: Conventional Stenting
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.
|
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.
Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence of coronary microvascular dysfunction
Time Frame: 1 day
|
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value < 2.5 U or angio IMR ≥ 25 U
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Major adverse cardiovascular events
Time Frame: 1 year
|
composite of nonfatal stroke, nonfatal myocardial infarction, heart failure, target vessel revascularization and cardiovascular death.
|
1 year
|
|
The incidence of coronary microvascular dysfunction
Time Frame: 1 year
|
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value < 2.5 U or angio IMR ≥ 25 U
|
1 year
|
|
Seattle Angina Questionnaire score
Time Frame: 1 year
|
Evaluates the severity of angina symptoms, physical limitations, and quality of life
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ali Aldujeli, Lithuanian University of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LUHSKC-179
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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