Acute Myocardial InfarctionITEMMRINCT01401881
Ischemic Time and Extent of Myocardial Infarction (MI) With Cardiac Magnetic Resonance Imaging (CMRI) in Patients With ST Elevation Myocardial Infarction (STEMI) and Primary Percutaneous Coronary Intervention (PCI) Study
An observational study of Acute Myocardial Infarction, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This study will assess relationship between ischemic time and the extent of myocardial infarction with cardiac magnetic resonance image in patients with STEMI (ST elevation myocardial infarction) and primary percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jul 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients with acute STEMI and primary PCI with clear identification of symptoms onset, willing to participate in the research protocol and not having any of the exclusion criteria. Patient screening will take place after the primary PCI in the cardiac catheterization laboratory or in the coronary care unit. Participation will be offered to all those who meet eligibility criteria.
Who may be able to join
- Clinical features, EKG, cTn elevation, and coronary catheterization findings consistent with an acute STEMI and having primary PCI, with age greater than 18 years, and GFR >= 60 mL/min/1.73m2.
Who cannot join
- Renal dysfunction (creatinine clearance < 60 mL/min/1.73m2)
- Pregnancy or breast-feeding
- Standard contra-indications to MRI for implanted ferro-magnetic devices - i.e.: pacemakers, defibrillator (AICD), and aneurysm clips
- Body weight > 400lb
- Unwilling to participate in the research protocol
- History of allergic reactions to gadlinium based contrast agents.
- Too critically ill to receive a MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Ischemic Time and Extent of Myocardial Infarction With Cardiac Magnetic Resonance Image in Patients With STEMI and Primary Percutaneous Coronary Intervention Study
This study will assess relationship between ischemic time and the extent of myocardial infarction with cardiac magnetic resonance image in patients with STEMI (ST elevation myocardial infarction) and primary percutaneous coronary intervention.
Read the detailed description
Background:
Cardiac magnetic resonance image (CMRI) is the preferred method of assessing myocardial infarct size and function. However,the relationship between CMRI changes and the ischemic time [symptom onset to device activation time (S2D)] in patients with primary percutaneous coronary intervention (PCI) is not well understood.
Hypothesis:
The investigators will test the primary hypothesis that there is strong (at least 70%) direct correlation between the S2D time and infarct size by CMRI and inverse correlation with myocardial salvage.
Method:
The investigators will study a prospective cohort of 80 consecutive patients with STEMI and primary PCI. The investigators will perform CMRI at day 3 to 1 post STEMI and a repeat CMRI 30 to 40 days post STEMI.
Exclusion Criteria:
The investigators will exclude patients with 1)-culprit lesion in the distal artery, 2)-glomerular filtration rate (GFR) < 60 mL/min/1.73m2, 3)-pacemaker, defibrillator, aneurysm clips, 4)-body weight > 400lb, 5)-history of allergic reactions to gadlinium based contrast agents, and 6)-those unwilling to participate in the study protocol.
Outcome Measurement:
The primary outcome measure is the CMRI myocardial infarct size (scar). The secondary outcomes include the CMRI transmurality of scar, area at risk, myocardial salvage index, microvascular obstruction (MVO), left ventricle (LV) thrombus, and LV ejection fraction (EF). Important covariates include symptoms and ST segment resolution before and after the PCI, peak cardiac troponin (cTn), and angiographic TIMI flow and myocardial perfusion grade.
Follow-up:
Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
- Conditions
- Acute Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post STEMI | The study population will consist of adult patients with acute STEMI and primary PCI with clear identification of symptoms onset, willing to participate in the research protocol and not having any of the exclusion criteria. Patient screening will take place after the primary PCI in the cardiac catheterization laboratory or in the coronary care unit. Participation will be offered to all those who meet eligibility criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMRI myocardial infarct size
The primary outcome measure is the CMRI myocardial infarct size (scar).
Measured: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
Secondary outcomes (6)
CMRI transmurality of scar
The secondary outcomes include the CMRI transmurality of scar, area at risk, myocardial salvage index, microvascular obstruction (MVO), left ventricle (LV) thrombus, and LV ejection fraction (EF). Important covariates include symptoms and ST segment resolution before and after the PCI, peak cardiac troponin (cTn), and angiographic TIMI flow and myocardial perfusion grade.
Measured: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
CMRI area at risk
The secondary outcomes include the CMRI transmurality of scar, area at risk, myocardial salvage index, microvascular obstruction (MVO), left ventricle (LV) thrombus, and LV ejection fraction (EF). Important covariates include symptoms and ST segment resolution before and after the PCI, peak cardiac troponin (cTn), and angiographic TIMI flow and myocardial perfusion grade.
Measured: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
CMRI myocardial salvage index
The secondary outcomes include the CMRI transmurality of scar, area at risk, myocardial salvage index, microvascular obstruction (MVO), left ventricle (LV) thrombus, and LV ejection fraction (EF). Important covariates include symptoms and ST segment resolution before and after the PCI, peak cardiac troponin (cTn), and angiographic TIMI flow and myocardial perfusion grade.
Measured: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
CMRI microvascular obstruction (MVO)
The secondary outcomes include the CMRI transmurality of scar, area at risk, myocardial salvage index, microvascular obstruction (MVO), left ventricle (LV) thrombus, and LV ejection fraction (EF). Important covariates include symptoms and ST segment resolution before and after the PCI, peak cardiac troponin (cTn), and angiographic TIMI flow and myocardial perfusion grade.
Measured: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months
CMRI left ventricle (LV) thrombus
The secondary outcomes include the CMRI transmurality of scar, area at risk, myocardial salvage index, microvascular obstruction (MVO), left ventricle (LV) thrombus, and LV ejection fraction (EF). Important covariates include symptoms and ST segment resolution before and after the PCI, peak cardiac troponin (cTn), and angiographic TIMI flow and myocardial perfusion grade.
Measured: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
CMRI LV ejection fraction (EF)
The secondary outcomes include the CMRI transmurality of scar, area at risk, myocardial salvage index, microvascular obstruction (MVO), left ventricle (LV) thrombus, and LV ejection fraction (EF). Important covariates include symptoms and ST segment resolution before and after the PCI, peak cardiac troponin (cTn), and angiographic TIMI flow and myocardial perfusion grade.
Measured: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startDec 2009
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ron Waksman, MD, Study director, WHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401881
- Sponsor's protocol ID
- ITEMMRI
- Acronym
- ITEMMRI
- Status last verified
- Apr 2013
- First submitted
- 28 May 2010
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Time and Extent of Myocardial Infarction With Cardiac Magnetic Resonance Image in Patients With STEMI and Primary Percutaneous Coronary Intervention Study
- ClinicalTrials.gov ID
- NCT01401881
- Acronym / sponsor ID
- ITEMMRI / ITEMMRI
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 25 Jul 2011 (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.
This study will assess relationship between ischemic time and the extent of myocardial infarction with cardiac magnetic resonance image in patients with STEMI (ST elevation myocardial infarction) and primary percutaneous coronary intervention.
Detailed description
Background:
Cardiac magnetic resonance image (CMRI) is the preferred method of assessing myocardial infarct size and function. However,the relationship between CMRI changes and the ischemic time [symptom onset to device activation time (S2D)] in patients with primary percutaneous coronary intervention (PCI) is not well understood.
Hypothesis:
The investigators will test the primary hypothesis that there is strong (at least 70%) direct correlation between the S2D time and infarct size by CMRI and inverse correlation with myocardial salvage.
Method:
The investigators will study a prospective cohort of 80 consecutive patients with STEMI and primary PCI. The investigators will perform CMRI at day 3 to 1 post STEMI and a repeat CMRI 30 to 40 days post STEMI.
Exclusion Criteria:
The investigators will exclude patients with 1)-culprit lesion in the distal artery, 2)-glomerular filtration rate (GFR) < 60 mL/min/1.73m2, 3)-pacemaker, defibrillator, aneurysm clips, 4)-body weight > 400lb, 5)-history of allergic reactions to gadlinium based contrast agents, and 6)-those unwilling to participate in the study protocol.
Outcome Measurement:
The primary outcome measure is the CMRI myocardial infarct size (scar). The secondary outcomes include the CMRI transmurality of scar, area at risk, myocardial salvage index, microvascular obstruction (MVO), left ventricle (LV) thrombus, and LV ejection fraction (EF). Important covariates include symptoms and ST segment resolution before and after the PCI, peak cardiac troponin (cTn), and angiographic TIMI flow and myocardial perfusion grade.
Follow-up:
Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post STEMI | – | –The study population will consist of adult patients with acute STEMI and primary PCI with clear identification of symptoms onset, willing to participate in the research protocol and not having any of the exclusion criteria. Patient screening will take place after the primary PCI in the cardiac catheterization laboratory or in the coronary care unit. Participation will be offered to all those who meet eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients with acute STEMI and primary PCI with clear identification of symptoms onset, willing to participate in the research protocol and not having any of the exclusion criteria. Patient screening will take place after the primary PCI in the cardiac catheterization laboratory or in the coronary care unit. Participation will be offered to all those who meet eligibility criteria.
Key inclusion criteria (1 listed)
- Clinical features, EKG, cTn elevation, and coronary catheterization findings consistent with an acute STEMI and having primary PCI, with age greater than 18 years, and GFR >= 60 mL/min/1.73m2.
Key exclusion criteria (7 listed)
- Renal dysfunction (creatinine clearance < 60 mL/min/1.73m2)
- Pregnancy or breast-feeding
- Standard contra-indications to MRI for implanted ferro-magnetic devices - i.e.: pacemakers, defibrillator (AICD), and aneurysm clips
- Body weight > 400lb
- Unwilling to participate in the research protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CMRI myocardial infarct size
Time frame: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
The primary outcome measure is the CMRI myocardial infarct size (scar).
6 secondary outcomes
CMRI transmurality of scar
Time frame: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
CMRI area at risk
Time frame: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
CMRI myocardial salvage index
Time frame: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
CMRI microvascular obstruction (MVO)
Time frame: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months
CMRI left ventricle (LV) thrombus
Time frame: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
CMRI LV ejection fraction (EF)
Time frame: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
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.
Ron Waksman, MD study director
WHC
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 Acute Myocardial Infarction, run by Medstar Health Research Institute 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 1 inclusion and 7 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 23 Apr 2013. 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?
Results are not available in the source record.
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?
CMRI myocardial infarct size (time frame: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.). 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 23 Apr 2013.