Condition or disease | Intervention/treatment | Phase |
---|---|---|
STEMI - ST Elevation Myocardial Infarction | Device: Excimer laser catheter | Not Applicable |
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:
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 (Clinical Trial) |
Actual Enrollment : | 248 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Masking Description: | Open -but assessors are blinded |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | July 26, 2018 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2030 |
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.
|
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The inclusion and exclusion criteria for the MRI will follow the main study, but in addition, will exclude following conditions.
Japan | |
Tokai University School of Medicine | |
Isehara, Kanagawa, Japan, 259-1193 |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | April 20, 2019 | ||||
First Posted Date ICMJE | May 15, 2019 | ||||
Last Update Posted Date | October 8, 2020 | ||||
Actual Study Start Date ICMJE | July 26, 2018 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Laser Atherectomy for ST Elevation Myocardial Infarction | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. | ||||
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:
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 ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Masking Description: Open -but assessors are blinded Primary Purpose: Treatment
|
||||
Condition ICMJE | STEMI - ST Elevation Myocardial Infarction | ||||
Intervention ICMJE | 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.
|
||||
Study Arms ICMJE |
|
||||
Publications * |
|
||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Actual Enrollment ICMJE |
248 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2030 | ||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
The inclusion and exclusion criteria for the MRI will follow the main study, but in addition, will exclude following conditions.
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 21 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03950310 | ||||
Other Study ID Numbers ICMJE | LASTPASS | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Yuji Ikari, Tokai University | ||||
Study Sponsor ICMJE | Tokai University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Tokai University | ||||
Verification Date | October 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |