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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 (ITEMMRI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01401881
First received: May 28, 2010
Last updated: April 22, 2013
Last verified: April 2013

May 28, 2010
April 22, 2013
December 2009
July 2013   (final data collection date for 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. ] [ Designated as safety issue: No ]
The primary outcome measure is the CMRI myocardial infarct size (scar).
Same as current
Complete list of historical versions of study NCT01401881 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
    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.
  • 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. ] [ Designated as safety issue: No ]
    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.
  • 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. ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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. ] [ Designated as safety issue: No ]
    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.
  • 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. ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Acute Myocardial Infarction
Not Provided
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion 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:

  1. Renal dysfunction (creatinine clearance < 60 mL/min/1.73m2)
  2. Pregnancy or breast-feeding
  3. Standard contra-indications to MRI for implanted ferro-magnetic devices - i.e.: pacemakers, defibrillator (AICD), and aneurysm clips
  4. Body weight > 400lb
  5. Unwilling to participate in the research protocol
  6. History of allergic reactions to gadlinium based contrast agents.
  7. Too critically ill to receive a MRI
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01401881
ITEMMRI
No
Medstar Research Institute
Medstar Research Institute
Not Provided
Study Director: Ron Waksman, MD WHC
Medstar Research Institute
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP