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

Acute Myocardial Infarction Clinical Trial

— ITEMMRI  

Official title:

Ischemic Time and Extent of Myocardial Infarction With Cardiac Magnetic Resonance Image in Patients With STEMI and Primary Percutaneous Coronary Intervention Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01401881
• Other study ID #: ITEMMRI
• Status: Active, not recruiting
• Phase: N/A
• First received: May 28, 2010
• Last updated: April 22, 2013
• Start date: December 2009
• Est. completion date: July 2013

Study information

• Verified date: April 2013
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.	No
Secondary	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.	Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.	No
Secondary	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.	Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.	No
Secondary	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.	Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months	No
Secondary	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.	Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.	No
Secondary	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.	Patients will be followed with repeat CMRI at 30 to 40 days and with phone survey at 6 months and 12 months.	No