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

November 10, 2023 updated by: Ali Aldujeli, Lithuanian University of Health Sciences

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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.

Diagnostic test: Angiography-derived index of microcirculatory resistance (IMRangio)
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.
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.

Diagnostic test: Angiography-derived index of microcirculatory resistance (IMRangio)
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

This is where you will find people and organizations involved with this study.

Sponsor

Lithuanian University of Health Sciences

Collaborators

Klaipėda University
Kreiskrankenhaus Rotenburg an der fluda
Alkafeel Super Speciality Hospital

Investigators

  • Principal Investigator: Ali Aldujeli, Lithuanian University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 5, 2023

First Submitted That Met QC Criteria

March 5, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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