An observational study in Acute Myocardial Infarction, sponsored by Medstar Health Research Institute. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-04-23.
Sponsored by Medstar Health Research Institute · Observational
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's planned enrollment of 80 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
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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.
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.
Exclusion Criteria:
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.
CMRI myocardial infarct size
The primary outcome measure is the CMRI myocardial infarct size (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 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.
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
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.
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
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.
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)
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.
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
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.
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)
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.
Time frame: Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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Medstar Health Research Institute