Stable AnginaMICRO-ROTANCT05771961
Impact of Rotational Atherectomy on Coronary Microcirculation
A study testing coronary pressure/temperature sensor-tipped guidewire and Angiography-derived index of microcirculatory resistance (IMRangio) in people with Stable Angina and Coronary Artery Disease, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stable Angina, Coronary Artery Disease
- What is being tested?
- coronary pressure/temperature sensor-tipped guidewire and Angiography-derived index of microcirculatory resistance (IMRangio)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteLithuania
- Study dates
- 1 May 2023to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed with stable coronary artery calcified lesion requiring Percutaneous coronary intervention
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, LT-50161
Ali Aldujeli, 864874874, ali.aldujeli@kaunoklinikos.lt
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Stable Angina, Coronary Artery Disease
- Being tested
- coronary pressure/temperature sensor-tipped guidewire, Angiography-derived index of microcirculatory resistance (IMRangio)
- Keywords
- Rotational atherectomy, Conventional stenting, CMD, Microcirculation, Index of microcirculatory resistance, IMRangio
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary pressure/temperature sensor-tipped guidewireDiagnostic test
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)Diagnostic test
Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software
| Study group | Role | What they receive |
|---|---|---|
| Rotational Atherectomy | Active comparator | 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. Receives: Diagnostic Test: coronary pressure/temperature sensor-tipped guidewire; Diagnostic Test: Angiography-derived index of microcirculatory resistance (IMRangio) |
| Conventional Stenting | Active comparator | 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. Receives: Diagnostic Test: coronary pressure/temperature sensor-tipped guidewire; Diagnostic Test: Angiography-derived index of microcirculatory resistance (IMRangio) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
Rate of Major adverse cardiovascular events
composite of nonfatal stroke, nonfatal myocardial infarction, heart failure, target vessel revascularization and cardiovascular death.
Measured: 1 year
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
Measured: 1 year
Seattle Angina Questionnaire score
Evaluates the severity of angina symptoms, physical limitations, and quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start1 May 2023
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to receive either the rotational atherectomy or conventional stenting alone.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Klaipėda University, Kreiskrankenhaus Rotenburg an der fluda, Alkafeel Super Speciality Hospital
- Responsible party
- Principal investigator, Ali Aldujeli, Lithuanian University of Health Sciences
- Investigators
- Ali Aldujeli, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771961
- Sponsor's protocol ID
- LUHSKC-179
- Acronym
- MICRO-ROTA
- Status last verified
- Nov 2023
- First submitted
- 5 Mar 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rotational Atherectomy on Coronary Microvascular Function in Patients With Stable Angina and Calcified Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05771961
- Acronym / sponsor ID
- MICRO-ROTA / LUHSKC-179
- Conditions
- Stable Angina, Coronary Artery Disease
- Keywords
- Rotational atherectomy, Conventional stenting, CMD, Microcirculation, Index of microcirculatory resistance, IMRangio
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Klaipėda University, Kreiskrankenhaus Rotenburg an der fluda, Alkafeel Super Speciality Hospital
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to receive either the rotational atherectomy or conventional stenting alone.
| Arm | Type | Receives |
|---|---|---|
| Rotational Atherectomy | Active comparator | Diagnostic Test: coronary pressure/temperature sensor-tipped guidewire, Diagnostic Test: Angiography-derived index of microcirculatory resistance (IMRangio)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. |
| Conventional Stenting | Active comparator | Diagnostic Test: coronary pressure/temperature sensor-tipped guidewire, Diagnostic Test: Angiography-derived index of microcirculatory resistance (IMRangio)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient diagnosed with stable coronary artery calcified lesion requiring Percutaneous coronary intervention
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary pressure/temperature sensor-tipped guidewireIn 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 | Conventional Stenting, Rotational Atherectomy |
| Angiography-derived index of microcirculatory resistance (IMRangio)Angiography-derived index of microcirculatory resistance (IMRangio) will be calculated by an anticipated software | Diagnostic test | Conventional Stenting, Rotational Atherectomy |
Primary outcome
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
3 secondary outcomes
Rate of Major adverse cardiovascular events
Time frame: 1 year
The incidence of coronary microvascular dysfunction
Time frame: 1 year
Seattle Angina Questionnaire score
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Aldujeli principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary pressure/temperature sensor-tipped guidewire and Angiography-derived index of microcirculatory resistance (IMRangio) in people with Stable Angina and Coronary Artery Disease, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Aldujeli (+37064874874, ali.aldujeli@kaunoklinikos.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of coronary microvascular dysfunction (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.