Impact of Rotational Atherectomy on Coronary Microcirculation

Coronary Artery Disease Clinical Trial

— MICRO-ROTA  

Official title:

Impact of Rotational Atherectomy on Coronary Microvascular Function in Patients With Stable Angina and Calcified Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771961
• Other study ID #: LUHSKC-179
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: November 2023
• Source: Lithuanian University of Health Sciences
• Contact: Ali Aldujeli
• Phone: +37064874874
• Email: ali.aldujeli[@]kaunoklinikos.lt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina

Intervention

Diagnostic Test:
• coronary pressure/temperature sensor-tipped guidewire
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)
Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (4)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Alkafeel Super Speciality Hospital, Klaipeda University, Kreiskrankenhaus Rotenburg an der fluda

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 day
Secondary	Rate of Major adverse cardiovascular events	composite of nonfatal stroke, nonfatal myocardial infarction, heart failure, target vessel revascularization and cardiovascular death.	1 year
Secondary	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	1 year
Secondary	Seattle Angina Questionnaire score	Evaluates the severity of angina symptoms, physical limitations, and quality of life	1 year