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
  Purpose

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.


Condition
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ischemic Time and Extent of Myocardial Infarction With Cardiac Magnetic Resonance Image in Patients With STEMI and Primary Percutaneous Coronary Intervention Study

Resource links provided by NLM:


Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: December 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401881

Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Research Institute
Investigators
Study Director: Ron Waksman, MD WHC
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01401881     History of Changes
Other Study ID Numbers: ITEMMRI
Study First Received: May 28, 2010
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014