Laser Atherectomy for ST Elevation Myocardial Infarction

September 29, 2022 updated by: Yuji Ikari, Tokai University

Evaluation of Myocardial Salvage by Scintigraphy After Excimer Laser Coronary Angioplasty and Percutaneous Coronary Intervention With Biodegradable-polymer Platinum Chromium Everolimus-eluting Stent in the Patients With Anterior ST Elevation Myocardial Infarction

The objectives of this study are to observe and examine prospectively whether excimer laser coronary angioplasty (ELCA) and percutaneous coronary intervention with biodegradable-polymer platinum chromium everolimus-eluting stent may improve the myocardial salvage in the patients with anterior ST elevation myocardial infarction (STEMI) using the myocardial scintigram (acute-phase I123-BMIPP and chronic-phase 99mTc-tetrofosmin), and to clarify the myocardial protective effect of excimer laser in the patients with anterior STEMI.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The clinical result of catheter treatment in the patients with acute myocardial infarction in these several decades improved because of progress of early reperfusion therapy and stent treatment technique. However, the no-reflow phenomenon is still remaining as a problem, which is involved in a decrease in left ventricular function and worsening of prognosis. It is considered that the no-reflow phenomenon is induced by atherosclerotic and thrombotic emboli, endothelial dysfunction of capillary vessels, free radicals and cytokine. The treatment combining the peripheral protection and thrombus aspiration aiming at prevention of no-reflow is expected to reduce no-reflow and the infarct size and has been conducted on the patients with acute myocardial infarction. However, a lot of randomized studies have been conducted, so far, which do not lead to reduction of infarct size and improvement of survival rate, and the efficacy has not been demonstrated.

Some explanations have been suggested for this phenomenon:

  1. The operation method of device is complicated, and it is difficult to acquire the treatment technique.
  2. Giant thrombus and solid lesion could not be aspirated effectively.
  3. A lot of randomized studies have not focused on the "patients with anterior descending lesion of thrombolysis in myocardial infarction (TIMI) grade 0/1, of which the time from onset to treatment is within 6 hours," considered to have the largest benefit of prevention of no-reflow.

In recent years in Japan, excimer laser coronary angioplasty (ELCA) has been used in the patients with acute coronary syndrome (ACS), and not only debulking of arteriosclerotic lesion but also thrombolytic effect have been reported. In the Camel trial and Utility of Laser for Transcatheter Atherectomy Multicenter Analysis around Naniwa (ULTRAMAN) registry, the efficacy and safety in ACS have been reported, but the infarct size has not been evaluated.

This time in this study, it is considered that verification whether or not ELCA is able to improve the myocardial salvage in anterior ST elevation myocardial infarction (STEMI) using myocardial scintigram (acute-phase BMIPP and chronic-phase TF) will provide the useful information helpful for selection of treatment to medical care staffs and patients for future patients suffering from ACS and will be able to contribute to further improvement of medical science and medical practice.

MRI will be performed twice at 5-9 days and at 6 months post index ST elevation myocardial infarction to assess myocardial damage and functional variables, which details will be described in the following outcome measurement section.

Study Type

Interventional

Enrollment (Actual)

142

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 Locations

  • Japan
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University School of Medicine

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

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients to whom PCI treatment for anterior STEMI is indicated [Main selection criteria]
  • First-episode anterior STEMI patients within 6 hours of onset that satisfy electrocardiogram criteria
  • Patients who are 21 years of age or older at the time of consent acquisition
  • Patient who the patient himself agreed in writing

Exclusion Criteria:

  • Patients presenting cardiac shock at the time of visit
  • Patients whose target lesions are left main trunk, circumflex, right coronary artery, distal anterior descending branch
  • Patients who have TIMI 2, 3 at the initial imaging
  • Patients with a reference vessel diameter of 2.5 mm or less
  • Patients determined to lack consent ability for mental or other reasons
  • Patient who is judged inappropriate by research researcher or research sharing doctor

The inclusion and exclusion criteria for the MRI will follow the main study, but in addition, will exclude following conditions.

  • Atrial fibrillation subject at the timing of MRI scan
  • Internally implanted devices such as pacemakers or ICDs
  • Subject that is allergic to Gadolinium,
  • Subject with claustrophobia
  • Pregnancy

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ELCA
On the antegrade delivery of the laser catheter after wiring, we used safe laser techniques and injected saline before and during the laser procedure at a 0.5 mm/sec catheter advancement rate. Whether to perform a retrograde laser method depended on each operator. After ablation by ELCA, patients undergo balloon dilation via standard techniques, and as appropriate, receive drug-eluting stent deployment.
Device: Excimer laser catheter
The excimer laser catheter is equipped with multiple optical fibers on the periphery of the guide wire lumen corresponding to 0.014 inch, which is used for the purpose of reperfusion of barrier site of coronary artery. The connector on the front side is connected with the CVX-300 laser generator, and the tip at the top contact directly with the lesion. The laser catheter consisting of multiple optical fibers transmits the energy in the ultraviolet region from the CVX300 laser generator to the blockage in the blood vessel. The ultraviolet energy is transmitted from the tip of laser catheter, transpires the fibrous, calcified and arteriosclerotic lesion by light, and enables reperfusion in the lesion. The laser catheter has appropriate hydrophilic coating and easily follows the inside of coronary artery.
NO_INTERVENTION: non ELCA
In non ELCA group, the conventional PCI procedure, including thrombus aspiration, POBA, and stent implantation was performed. The indication for aspiration was at the discretion of the physician based on angiographic, intravascular ultrasound, or optical coherence tomography/Optical Frequency-Domain Imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial salvage (17 segment model) by SPECT
Time Frame: 3 day to 6 month
Calculation of score using software in the Core Lab (Tokai University, Department of Radiology). Scoring should be conducted in 17 segments and at 5 grades from 0 to 4 in each segment on the polar map images. The Myocardial salvage (17-segment) was calculated by subtracting the total sum of the 123I-BMIPP and 99mTc-tetrofosmin defect scores in each segment ( ∑123I-BMIPP defect score minus 99mTc-∑tetrofosmin defect score).
3 day to 6 month
Myocardial Salvage index (17 segment model) by SPECT
Time Frame: 3 day to 6 month
Salvage index was calculated as follows: Myocardial Salvage index =∑123I-BMIPP defect score minus ∑99mTc-tetrofosmin defect score/ ∑123I-BMIPP defect score × 100 (%).
3 day to 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial scar amount assessment by MRI
Time Frame: 5-9 days and 6 month
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Myocardial scar amount assessed on Late Short Axis LGE image
5-9 days and 6 month
Microvascular obstruction assessment by MRI
Time Frame: 5-9 days and 6 month
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Microvascular obstruction on perfusion image and Early Short Axis LGE image
5-9 days and 6 month
Myocardial salvage assessment by MRI
Time Frame: 5-9 days and 6 month
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Myocardial salvage derived from T2WBB and Late Short Axis LGE images
5-9 days and 6 month
Ejection fraction assessment by MRI
Time Frame: 5-9 days and 6 month
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Ejection Fraction derived from Cine images
5-9 days and 6 month
Gray zone assessment by MRI
Time Frame: 5-9 days and 6 month
All the outcome values will be derived by MRI image assessment. Each variables values will be derived as follows: Gray zone derived from Late Short Axis LGE images.
5-9 days and 6 month
Left ventricular ejection fraction by TF scintigraphy at 6 months
Time Frame: 5-7 month
99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. ejection fraction (%) based on 99mTc-tetrofosmin QGS data.
5-7 month
Left ventricular volume (ml) by TF scintigraphy at 6 months
Time Frame: 5-7 month
99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. Left ventricular volume (ml) based on 99mTc-tetrofosmin QGS data.
5-7 month
Left ventricular end-diastolic volume (ml) by TF scintigraphy at 6 months
Time Frame: 5-7 month
99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. Left ventricular end-diastolic volume (ml) based on 99mTc-tetrofosmin QGS data.
5-7 month
Left ventricular end-systolic volume (ml) by TF scintigraphy at 6 months
Time Frame: 5-7 month
99mTc-tetrofosmin (TF) scintigraphy was performed 6 months after the PCI procedure. For the scanning procedure, the 740 MBq of 99mTc-tetrofosmin injected with patient while at rest. Left ventricular end-systolic volume (ml) on 99mTc-tetrofosmin QGS data.
5-7 month
Intra-stent tissue volume by OCT
Time Frame: at the end of procedure and 1-year
OCT analysis should be conducted by an independent core lab (Kobe University Hospital) before and after stenting at Primary PCI and 1 year after PCI in selected patients. Should be conducted preoperatively, postoperatively and 1 year after operation. For analysis, the required matters (catheter size and target lesion) should be entered into the technician worksheet. The size and length of the stent used should be entered, in particular. In conducting OCI imaging in each medical institution, attention should be paid to the following points, and the requirements should be entered in the given section of technician worksheet: Analysis should be conducted based on the stent length described in the technician worksheet. In the qualitative analysis, the inside of stent and 5 mm to proximal and distal ends of stent should be evaluated at the interval of 0.2 mm. In the quantitative analysis, the inside of stent should be evaluated at the interval of 1.0 mm.
at the end of procedure and 1-year
Myocardial salvage [total perfusion defect (TPD) model] by SPECT
Time Frame: 3 day to 6 month
Myocardial salvage [total perfusion defect model (TPD)] = (Risk at area: TPD measured by BMIPP 3-9 days after p-PCI) minus (Infarct size: TPD measured by Tc99m-tetrofosmin at 6 months after p-PCI)
3 day to 6 month
Myocardial salvage index (%) [total perfusion defect (TPD) model] by SPECT
Time Frame: 3 day to 6 month
Myocardial salvage index (%) [total perfusion defect model (TPD)] = myocardial salvage / Risk at area: TPD measured by BMIPP 3-9 days after p-PCI x 100
3 day to 6 month
Major adverse cardiovascular events (MACE) at 12 months
Time Frame: 12 months
Major adverse cardiovascular events (MACE) MACE were defined as all-cause death, myocardial infarction (MI), or target lesion revascularization (TLR).
12 months
Major adverse cardiovascular events (MACE) at 36 months
Time Frame: 36 months
Major adverse cardiovascular events (MACE) MACE were defined as all-cause death, myocardial infarction (MI), or target lesion revascularization (TLR).
36 months
Major adverse cardiovascular events (MACE) at 60 months
Time Frame: 60 months
Major adverse cardiovascular events (MACE) MACE were defined as all-cause death, myocardial infarction (MI), or target lesion revascularization (TLR).
60 months
Cardiac death at 12 months
Time Frame: 12 months
Death was considered to be of cardiac origin unless obvious noncardiac causes could be identified.
12 months
Cardiac death at 36 months
Time Frame: 36 months
Death was considered to be of cardiac origin unless obvious noncardiac causes could be identified.
36 months
Cardiac death at 60 months
Time Frame: 60 months
Death was considered to be of cardiac origin unless obvious noncardiac causes could be identified.
60 months

Collaborators and Investigators

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

Sponsor

Tokai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 26, 2018

Primary Completion (ACTUAL)

December 31, 2021

Study Completion (ACTUAL)

December 31, 2021

Study Registration Dates

First Submitted

April 20, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (ACTUAL)

May 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LASTPASS

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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