Coronary Artery DiseaseMECHANISM-AMINCT02014753
Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN studIeS for TreatMent of Acute Myocardial InfarctionTreatment of ST-elevation Acute Myocardial Infarction
An observational study of Coronary Artery Disease, run by Iwate Medical University at 1 site in Japan.
Trial summary
To treat patients with acute myocardial infarction, primary percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- cobalt-chromium everolimus-eluting stent (CoCr-EES)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 30 Apr 2014to 26 Jul 2016
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- AMI definition is accordance with the third universal definition of ESC /ACCF/ AHA/ WHF Task Force10, detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn) I or T] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundlebranch block (LBBB).
- Development of pathological Q waves in the ECG. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- Identification of an intracoronary thrombus by angiography or autopsy Of the AMI patients who met the above definition, the criterial for inclusion is limited to STEMI patients. STEMI is defined as new ST elevation at the J point in at least 2 contiguous leads of equal or greater than2 mm (0.2 mV) in men equal or greater than1.5 mm (0.15 mV) in women in leads V2-V3 and/or of equal or greater than 1 mm (0.1 mV) in other contiguous chest leads or the limb leads
- Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated.
- Patients aged 20 to less than 85 years at the time of informed consent
- Patients who have provided informed consent written by themselves
- Patients who are able to undergo OCT examinations of the site of stent placement at 2 weeks or 3 months and at 12 months.
Who cannot join
- Shock
- Patients who are judged incapable of undergoing clinical follow-up 12 months after PCI (Consider also the location of patients' residences)
- Lack of specific findings of ACS by angiography (Left to the operator's decision.)
- The culprit lesion is the left main coronary trunk
- Lesion with the reference vascular diameter less than 2.0mm or not less than 4.5mm by visual evaluation.
- Chronic renal failure with serum creatinine level not less than 2.0mg/dl on hospital visit
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- Patients on hemodialysis Cancer patients whose vital prognosis is expected to be within 2 years. Surgery that requires discontinuation of the antiplatelet agent is scheduled within 3 months
- Patients who experienced adverse reaction to aspirin or clopidogrel (this shall not apply for patients in whom safety of ticlopidine is confirmed)
- Patients who took warfarin before the onset
- Patients under 20 years old
- Pregnant women
- AMI due to stent thrombosis at prior stented segment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN studIeS for TreatMent of Acute Myocardial Infarction: MECHANISM-AMI
To treat patients with acute myocardial infarction, primary percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 2 weeks or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
- Conditions
- Coronary Artery Disease
- Being tested
- cobalt-chromium everolimus-eluting stent (CoCr-EES)
- Keywords
- AMI, STEMI, ACS
- Medical subject headings
- Coronary Artery Disease, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cobalt-chromium everolimus-eluting stent (CoCr-EES)Device
Also called XIENCE PRIME, XIENCE Xpedition
| Study group | Role | What they receive |
|---|---|---|
| CoCr-EES, 2-week OCT follow-up | Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 2-week after PCI. Receives: Device: cobalt-chromium everolimus-eluting stent (CoCr-EES) | |
| CoCr-EES, 3-month OCT follow-up | Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 3-month after PCI. Receives: Device: cobalt-chromium everolimus-eluting stent (CoCr-EES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of stent strut coverage by OCT
To observe temporal course from the early stage, the rate of stent-strut coverage in the 3-months arm will also be evaluated in a complementary manner, separately from the 2-weeks arm.
Measured: 2 weeks
Secondary outcomes (11)
All-cause Death, Cardiac death, Myocardial Infarction (MI), Stroke, Major bleeding
Measured: 1 year
Any Target Lesion Revascularization (TLR)
Measured: 1 year
Clinically-driven TLR
Measured: 1 year
Any Target Vessel Revascularization (TVR)
Measured: 1 year
Coronary-artery bypass surgery (CABG)
Measured: 1 year
Any revascularization
Measured: 1 year
Angiographic binary restenosis
Measured: 1 year
Patient-oriented composite
Composite of All-cause death, any MI including non-target territory, any repeat revascularization and Stroke
Measured: 1 year
OCT Endpoint
- The percentage of stent strut malapposition
- The presence of Intra-stent thrombus
- Intra-stent thrombus area (Maximum site)
- Intra-stent thrombus length
- The number of Intra-stent thrombus
Measured: 2 weeks and 3 months
Angiographic Quantitative analysis
- In-segment late loss
- Minimal lumen diameter (MLD), reference vessel diameter (RVD), percent diameter stenosis (%DS)
- In-stent late loss
- Binary restenosis (In-stent, In-segment, Peri-stent)
- Angiographically detected stent fracture（based on Popma's classification ）
- The number of Intra-stent thrombus
Measured: 12 month
Angiographic Qualitative analysis
- Peri-stent contrast stain (PSS)
- Site and pattern of restenosis (based on Mehran classification)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study start30 Apr 2014
- Primary completion25 Sep 2015
- Study completion26 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iwate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihiro Morino, Iwate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014753
- Sponsor's protocol ID
- MECHANISM-AMI
- Acronym
- MECHANISM-AMI
- Status last verified
- Mar 2019
- First submitted
- 12 Dec 2013
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN studIeS for TreatMent of Acute Myocardial Infarction: MECHANISM-AMI
- ClinicalTrials.gov ID
- NCT02014753
- Acronym / sponsor ID
- MECHANISM-AMI / MECHANISM-AMI
- Conditions
- Coronary Artery Disease
- Keywords
- AMI, STEMI, ACS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Iwate Medical UniversityUniversity, hospital or other
- Study start
- 30 Apr 2014 (actual)
- Primary completion
- 25 Sep 2015 (actual)
- Study completion
- 26 Jul 2016 (actual)
- First posted
- 18 Dec 2013 (estimated)
- 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.
To treat patients with acute myocardial infarction, primary percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 2 weeks or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoCr-EES, 2-week OCT follow-up | – | Device: cobalt-chromium everolimus-eluting stent (CoCr-EES)Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 2-week after PCI. |
| CoCr-EES, 3-month OCT follow-up | – | Device: cobalt-chromium everolimus-eluting stent (CoCr-EES)Undergo primary PCI with cobalt-chromium everolimus-eluting stent (CoCr-EES) for AMI culprit lesion and perform OCT observation at 3-month after PCI. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (7 listed)
- AMI definition is accordance with the third universal definition of ESC /ACCF/ AHA/ WHF Task Force10, detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn) I or T] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundlebranch block (LBBB).
- Development of pathological Q waves in the ECG. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- Identification of an intracoronary thrombus by angiography or autopsy Of the AMI patients who met the above definition, the criterial for inclusion is limited to STEMI patients. STEMI is defined as new ST elevation at the J point in at least 2 contiguous leads of equal or greater than2 mm (0.2 mV) in men equal or greater than1.5 mm (0.15 mV) in women in leads V2-V3 and/or of equal or greater than 1 mm (0.1 mV) in other contiguous chest leads or the limb leads
- Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated.
- Patients aged 20 to less than 85 years at the time of informed consent
Key exclusion criteria (12 listed)
- Shock
- Patients who are judged incapable of undergoing clinical follow-up 12 months after PCI (Consider also the location of patients' residences)
- Lack of specific findings of ACS by angiography (Left to the operator's decision.)
- The culprit lesion is the left main coronary trunk
- Lesion with the reference vascular diameter less than 2.0mm or not less than 4.5mm by visual evaluation.
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 |
|---|---|---|
| cobalt-chromium everolimus-eluting stent (CoCr-EES)Also: XIENCE PRIME, XIENCE Xpedition | Device | CoCr-EES, 2-week OCT follow-up, CoCr-EES, 3-month OCT follow-up |
Primary outcome
The percentage of stent strut coverage by OCT
Time frame: 2 weeks
To observe temporal course from the early stage, the rate of stent-strut coverage in the 3-months arm will also be evaluated in a complementary manner, separately from the 2-weeks arm.
11 secondary outcomes
All-cause Death, Cardiac death, Myocardial Infarction (MI), Stroke, Major bleeding
Time frame: 1 year
Any Target Lesion Revascularization (TLR)
Time frame: 1 year
Clinically-driven TLR
Time frame: 1 year
Any Target Vessel Revascularization (TVR)
Time frame: 1 year
Coronary-artery bypass surgery (CABG)
Time frame: 1 year
Any revascularization
Time frame: 1 year
Angiographic binary restenosis
Time frame: 1 year
Patient-oriented composite
Time frame: 1 year
OCT Endpoint
Time frame: 2 weeks and 3 months
Angiographic Quantitative analysis
Time frame: 12 month
Angiographic Qualitative analysis
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Iwate Medical University at 1 site in Japan.
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 7 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: finished, as of the sponsor's last update on 19 Mar 2019. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of stent strut coverage by OCT (time frame: 2 weeks). 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 19 Mar 2019.