Acute Myocardial InfarctionMIAMINCT02926755
Multi-modality Imaging in Acute Myocardial Infarction
A study testing Coronary Angiography in people with Acute Myocardial Infarction and STEMI, run by Corewell Health East at 1 site in United States.
Trial summary
The goal of this study is to use three (3) different imaging techniques:Fractional Flow Reserve (FFR) allows precise measurement of blood flow in the arteries to the heart, and is more reliable than pictures alone to determine the significance of blockages in the heart; Near Infra-Red Spectroscopy-Intravascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, STEMI, Coronary Artery Disease
- What is being tested?
- Coronary Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2016to 11 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with ST-elevation acute myocardial infarction (STEMI) and age > 18 years who meet all of the following criteria:
- Successful primary Percutaneous Intervention (PCI) of the Infarcted Related Artery (IRA) defined as final stenosis < 30%, Thrombolysis In Myocardial Infarction (TIMI) 3 flow
- At least 1 non-IRA with diameter stenosis ≥ 50% and reference vessel diameter > 2mm
- None of the exclusion criteria
Who cannot join
- Patients will be excluded if any of the following are present:
- Cardiogenic shock that persists > 24 hours after primary PCI
- Diffuse disease in non-IRA that precludes successful stenting
- Estimated Glomerular Filtration Rate (eGFR) < 30 cc/min/1.73 m2 after hydration or optimization of Congestive Heart Failure (CHF) for cardiac death
- eGFR <60 cc/min/1.73 m2, will be in the MIAMI study for invasive imaging treatment group/cohort but will not get the coronary CCTA
- eGFR < 60 cc/min/1.73 m2, for coronary CCTA
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- Active bleeding as defined as a fall in hemoglobin (HGB) concentration > 3 g/dL within 24 hours requiring blood transfusion, vasopressors to maintain Systolic BP > 100mmhg, or emergency surgical, endovascular, or endoscopic intervention.
- Mechanical complication of MI such as severe Mitral-Valve Regurgitation (MR), Ventricular Septal Defect (VSD) or pulmonary edema
- Uncontrolled Ventricular Tachycardia (VT) after primary PCI
- Inability to provide informed consent
- Ventilator-dependent respiratory failure
- Only non-IRA is a chronic total occlusion
- Non-IRA is in a Saphenous Vein Graft (SVG) or arterial graft
- Non-IRA is in the left main, ostial Left Anterior Descending (LAD), or ostial Left circumflex (LCX)
- Non-IRA includes a bifurcation with side branch > 2mm, medina 1-1-1
- Need for multivessel primary PCI during the index procedure
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to use three (3) different imaging techniques:Fractional Flow Reserve (FFR) allows precise measurement of blood flow in the arteries to the heart, and is more reliable than pictures alone to determine the significance of blockages in the heart; Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume; and Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; to evaluate high risk non-infarct-related coronary lesion in patients who have suffered a recent heart attack, underwent successful opening of the artery with a stent, and have blockages greater than or equal to 50% in one or more of the other arteries to the heart; and to correlate this findings with cardiovascular outcomes at 1 year.
Read the detailed description
This is a prospective, open-label, single center registry. The study is designed to characterize plaque (i.e., assess vulnerable plaque features such as plaque tears, plaque thickness, plaque volume, and lipid content in plaque) in heart arteries in patients who have suffered a recent acute heart attack, and who have blockages >50% in one or more of the other arteries in the heart. The procedure to do this will not be the same procedure that was done to open the artery that caused the heart attack, but will be scheduled 2-40 days after the first procedure, depending on the urgency to evaluate the other arteries and the stability of the patient after the first procedure. The study will specifically evaluate the plaque characteristics in the arteries that didn't cause the heart attack, to see if these arteries have vulnerable plaque and is at risk for future heart attacks. If FFR shows abnormal blood flow, these arteries will be treated with stents. All patients will be followed for 12 months after the second catheterization. The purpose of the study is to determine how commonly vulnerable plaques are identified in patients with acute heart attacks, and how often these lead to future cardiac problems. Identification of plaque features that lead to future problems may allow the development of new medications and devices to prevent future heart attacks and death. These same plaque features are also thought to be operative in patients with blockages in the arteries to the brain, so this study may have important implications for stroke prevention as well. All patients will be considered eligible for participation if they had a recent acute heart attack resulting from complete occlusion of an artery to the heart, if the stent procedure to open the artery was successful, and if they have blockages > 50% in at least one other major heart artery. Patients will not be eligible for participation if they are too unstable with regard to heart, lung, brain, or kidney function, or if they have previous bypasses to the heart.
In selected patients, Coronary CT Angiography (CCTA) will be performed after the initial procedure to open the artery within 40 days. CCTA images will be evaluated for plaque characteristics, and correlated with the invasive findings.Fractional flow reserve via computed tomography (FFRCT), a non-invasive computed tomography method of measuring blood flow in the blocked arteries; will also be determined and correlated with invasive FFR.
The standard portion of the procedure includes the angiogram (X-ray pictures of the arteries), FFR (measurement of blood flow in the artery), IVUS and/or OCT (to assess the diameter of the artery and the size of the stent), medications, and all office visits. The research portion of the study requires all imaging studies be performed (NIRS IVUS, OCT, FFR) rather than just one or two of these imaging studies, and the CCTA.
- Conditions
- Acute Myocardial Infarction, STEMI, Coronary Artery Disease, Atherosclerotic Plaque Disruption With Thrombosis of Artery
- Being tested
- Coronary Angiography
- Keywords
- Intra Venous Ultrasound (IVUS), Fractional Flow Reserve (FFR), Optical Coherence Tomography (OCT), Acute Myocardial Infarction, Coronary Artery Disease (CAD), Angiography
- Medical subject headings
- ST Elevation Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiographyProcedure or surgery
Coronary angiography which includes fractional flow reserve (FFR),that allows precise measurement of blood flow in the arteries to the heart; the Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume;the Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; and Coronary CT Angiography (CCTA) to evaluate plaque characteristics, and correlate with the invasive findings. The research portion of the study requires all imaging studies be performed (NIRS, IVUS, OCT, FFR) during coronary angiography, rather than just one or two of these imaging studies, and the CCTA.
| Study group | Role | What they receive |
|---|---|---|
| Angiography to Assess Vulnerable Plaque | Experimental | In order to characterize plaque a repeat Coronary Angiography within 2 to 40 days will be done to assess vulnerable plaque features such as plaque tears, plaque thickness, plaque volume, and lipid content in plaque) in heart arteries in patients who have suffered a recent acute heart attack, and who have blockages >50% in one or more of the other arteries in the heart. Receives: Procedure: Coronary Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured during cardiac cath
2-40 days after the first cardiac catheterization procedure, depending on the urgency to evaluate the other arteries and the stability of the patient after the first procedure. Repeat cardiac catheterization for Data Analysis Stenosis severity (using angiographic criteria defined as Diameter Stenosis (DS) > 70% and DS > 50%;
Measured: 40 Days
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by IVUS
Stenosis severity will be measured by IVUS criteria defined as minimal lumen cross sectional area (mCSA) < 4mm2, mCSA < 2.5mm2, plaque volume; and vulnerable plaque by IVUS-fibrous cap thickness.
Measured: 40 Days
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by FFR
cardiac catheterization with FFR criteria defined as FFR < 0.80;
Measured: 40 Days
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by OCT
Vulnerable plaque characteristics will be measured by OCT criteria - plaque ulceration, erosion, thrombus, fibrous cap thickness
Measured: 2 - 40 Days
Prevalence of hemodynamically-significant stenosis in non-infarct-related coronary arteries in STEMI patients as measured by CCTA
Stenosis severity will be measured by CCTA criteria-Diameter Stenosis >70%
Measured: 2 - 40 Days
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by NIRS
Vulnerable plaque characteristics will be measure by NIRS criteria - Lipid Core Burden Index (LCBI) - 4mm > 300, Lipid Core Containing Plaque (LCP) distribution
Measured: 2 - 40 Days
Secondary outcomes (2)
Incidence of cardiac events at 1-year after STEMI.
Correlation between cardiovascular outcomes (MACE) at 1-year with measures of stenosis severity and presence of ≥ 1 feature of vulnerable plaque.
Measured: 1 Year
Correlation with coronary angiography with imagings findings and Coronary CT Angiography (CCTA) imaging findings.
In selected patients, Coronary CT Angiography (CCTA) will be performed within 40 days after the initial procedure that opens the artery . CCTA images will be evaluated for plaque characteristics, and correlated with the invasive findings.Fractional flow reserve via computed tomography (FFRCT), a non-invasive computed tomography method of measuring blood flow in the blocked arteries; will also be determined and correlated with invasive FFR.
Measured: 40 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start20 Jan 2016
- Primary completion11 Feb 2019
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Safian, Corewell Health East
- Investigators
- Robert Safian, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926755
- Sponsor's protocol ID
- 2015-144
- Acronym
- MIAMI
- Status last verified
- Apr 2019
- First submitted
- 15 Aug 2016
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ihdayhid AR, Tzimas G, Peterson K, Ng N, Mirza S, Maehara A, Safian RD. Diagnostic Performance of AI-enabled Plaque Quantification from Coronary CT Angiography Compared with Intravascular Ultrasound. Radiol Cardiothorac Imaging. 2024 Dec;6(6):e230312. doi: 10.1148/ryct.230312.
PubMed 39540820
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modality Imaging in Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02926755
- Acronym / sponsor ID
- MIAMI / 2015-144
- Conditions
- Acute Myocardial Infarction, STEMI, Coronary Artery Disease, Atherosclerotic Plaque Disruption With Thrombosis of Artery
- Keywords
- Intra Venous Ultrasound (IVUS), Fractional Flow Reserve (FFR), Optical Coherence Tomography (OCT), Acute Myocardial Infarction, Coronary Artery Disease (CAD), Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- 20 Jan 2016 (actual)
- Primary completion
- 11 Feb 2019 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 6 Oct 2016 (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.
The goal of this study is to use three (3) different imaging techniques:Fractional Flow Reserve (FFR) allows precise measurement of blood flow in the arteries to the heart, and is more reliable than pictures alone to determine the significance of blockages in the heart; Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume; and Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; to evaluate high risk non-infarct-related coronary lesion in patients who have suffered a recent heart attack, underwent successful opening of the artery with a stent, and have blockages greater than or equal to 50% in one or more of the other arteries to the heart; and to correlate this findings with cardiovascular outcomes at 1 year.
Detailed description
This is a prospective, open-label, single center registry. The study is designed to characterize plaque (i.e., assess vulnerable plaque features such as plaque tears, plaque thickness, plaque volume, and lipid content in plaque) in heart arteries in patients who have suffered a recent acute heart attack, and who have blockages >50% in one or more of the other arteries in the heart. The procedure to do this will not be the same procedure that was done to open the artery that caused the heart attack, but will be scheduled 2-40 days after the first procedure, depending on the urgency to evaluate the other arteries and the stability of the patient after the first procedure. The study will specifically evaluate the plaque characteristics in the arteries that didn't cause the heart attack, to see if these arteries have vulnerable plaque and is at risk for future heart attacks. If FFR shows abnormal blood flow, these arteries will be treated with stents. All patients will be followed for 12 months after the second catheterization. The purpose of the study is to determine how commonly vulnerable plaques are identified in patients with acute heart attacks, and how often these lead to future cardiac problems. Identification of plaque features that lead to future problems may allow the development of new medications and devices to prevent future heart attacks and death. These same plaque features are also thought to be operative in patients with blockages in the arteries to the brain, so this study may have important implications for stroke prevention as well. All patients will be considered eligible for participation if they had a recent acute heart attack resulting from complete occlusion of an artery to the heart, if the stent procedure to open the artery was successful, and if they have blockages > 50% in at least one other major heart artery. Patients will not be eligible for participation if they are too unstable with regard to heart, lung, brain, or kidney function, or if they have previous bypasses to the heart.
In selected patients, Coronary CT Angiography (CCTA) will be performed after the initial procedure to open the artery within 40 days. CCTA images will be evaluated for plaque characteristics, and correlated with the invasive findings.Fractional flow reserve via computed tomography (FFRCT), a non-invasive computed tomography method of measuring blood flow in the blocked arteries; will also be determined and correlated with invasive FFR.
The standard portion of the procedure includes the angiogram (X-ray pictures of the arteries), FFR (measurement of blood flow in the artery), IVUS and/or OCT (to assess the diameter of the artery and the size of the stent), medications, and all office visits. The research portion of the study requires all imaging studies be performed (NIRS IVUS, OCT, FFR) rather than just one or two of these imaging studies, and the CCTA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angiography to Assess Vulnerable Plaque | Experimental | Procedure: Coronary AngiographyIn order to characterize plaque a repeat Coronary Angiography within 2 to 40 days will be done to assess vulnerable plaque features such as plaque tears, plaque thickness, plaque volume, and lipid content in plaque) in heart arteries in patients who have suffered a recent acute heart attack, and who have blockages >50% in one or more of the other arteries in the heart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with ST-elevation acute myocardial infarction (STEMI) and age > 18 years who meet all of the following criteria:
- Successful primary Percutaneous Intervention (PCI) of the Infarcted Related Artery (IRA) defined as final stenosis < 30%, Thrombolysis In Myocardial Infarction (TIMI) 3 flow
- At least 1 non-IRA with diameter stenosis ≥ 50% and reference vessel diameter > 2mm
- None of the exclusion criteria
Key exclusion criteria (16 listed)
- Cardiogenic shock that persists > 24 hours after primary PCI
- Diffuse disease in non-IRA that precludes successful stenting
- Estimated Glomerular Filtration Rate (eGFR) < 30 cc/min/1.73 m2 after hydration or optimization of Congestive Heart Failure (CHF) for cardiac death
- eGFR <60 cc/min/1.73 m2, will be in the MIAMI study for invasive imaging treatment group/cohort but will not get the coronary CCTA
- eGFR < 60 cc/min/1.73 m2, for coronary CCTA
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 AngiographyCoronary angiography which includes fractional flow reserve (FFR),that allows precise measurement of blood flow in the arteries to the heart; the Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume;the Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; and Coronary CT Angiography (CCTA) to evaluate plaque characteristics, and correlate with the invasive findings. The research portion of the study requires all imaging studies be performed (NIRS, IVUS, OCT, FFR) during coronary angiography, rather than just one or two of these imaging studies, and the CCTA. | Procedure or surgery | Angiography to Assess Vulnerable Plaque |
Primary outcome
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured during cardiac cath
Time frame: 40 Days
2-40 days after the first cardiac catheterization procedure, depending on the urgency to evaluate the other arteries and the stability of the patient after the first procedure. Repeat cardiac catheterization for Data Analysis Stenosis severity (using angiographic criteria defined as Diameter Stenosis (DS) > 70% and DS > 50%;
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by IVUS
Time frame: 40 Days
Stenosis severity will be measured by IVUS criteria defined as minimal lumen cross sectional area (mCSA) < 4mm2, mCSA < 2.5mm2, plaque volume; and vulnerable plaque by IVUS-fibrous cap thickness.
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by FFR
Time frame: 40 Days
cardiac catheterization with FFR criteria defined as FFR < 0.80;
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by OCT
Time frame: 2 - 40 Days
Vulnerable plaque characteristics will be measured by OCT criteria - plaque ulceration, erosion, thrombus, fibrous cap thickness
Prevalence of hemodynamically-significant stenosis in non-infarct-related coronary arteries in STEMI patients as measured by CCTA
Time frame: 2 - 40 Days
Stenosis severity will be measured by CCTA criteria-Diameter Stenosis >70%
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured by NIRS
Time frame: 2 - 40 Days
Vulnerable plaque characteristics will be measure by NIRS criteria - Lipid Core Burden Index (LCBI) - 4mm > 300, Lipid Core Containing Plaque (LCP) distribution
2 secondary outcomes
Incidence of cardiac events at 1-year after STEMI.
Time frame: 1 Year
Correlation with coronary angiography with imagings findings and Coronary CT Angiography (CCTA) imaging findings.
Time frame: 40 Days
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 10 Apr 2019.
- Derived from this study: PubMed 39540820Ihdayhid AR, Tzimas G, Peterson K, Ng N, Mirza S, Maehara A, Safian RD. Diagnostic Performance of AI-enabled Plaque Quantification from Coronary CT Angiography Compared with Intravascular Ultrasound. Radiol Cardiothorac Imaging. 2024 Dec;6(6):e230312. doi: 10.1148/ryct.230312.
- Individual participant dataSharing planned: No
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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.
Robert Safian, MD principal investigator
Corewell Health East
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 Angiography in people with Acute Myocardial Infarction and STEMI, run by Corewell Health East at 1 site in United States.
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 4 inclusion and 16 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 10 Apr 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 United States. 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?
Prevalence of hemodynamically-significant stenosis and "vulnerable" plaque in non-infarct-related coronary arteries in STEMI patients as measured during cardiac cath (time frame: 40 Days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02926755, which also lists 1 linked publication.
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 10 Apr 2019.