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

NCT01401881 | Unknown

• 1 other identifier: ITEMMRI
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• CMRI myocardial infarct size

  The primary outcome measure is the CMRI myocardial infarct size (scar).

  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

  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

  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

  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)

  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

  Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Study Officials

• Ron Waksman, MD

  WHC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: July 25, 2011
• Study Start: December 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)