Prognostic Impact and Arrhythmic Potential of Peri-Infarct Zone by Cardiac MRI - Full Text View

Purpose

The purpose of this study is to determine if the size of the peri-infarct zone assessed by cardiac MRI at 2 to 4 weeks after an ST elevation myocardial infarction(STEMI) provides additional value in predicting sudden cardiac death. The study also aims to investigate

the possible protective effect of omega-3 fatty acids in preventing sudden cardiac death and effects of omega-3 fatty acids on size of peri-infarct zone ,
analyzing genetic sequences that may cause an individual to be at a higher risk of causing sudden cardiac death post STEMI,
Analyzing inflammatory biomarkers that may be predictive of sudden cardiac death after a STEMI, AND
Analyzing predictive power of microvolt T wave alternans in predicting sudden cardiac death after a STEMI.

Condition	Intervention	Phase
Myocardial Infarction Sudden Cardiac Death	Drug: Omega -3 fatty Acids Drug: Placebo	Phase III

MedlinePlus related topics:

Cardiac Arrest Heart Attack

ChemIDplus related topics:

Omacor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Official Title:	Prognostic Impact and Arrhythmic Potential of Peri-Infarct Zone by Cardiac MRI

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Predictive value of Peri-infarct zone on Sudden Cardiac Death [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect of Omega-3 fatty acids on Sudden Cardiac Death post STEMI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	414
Study Start Date:	August 2008
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Experimental Patients in this arm will be given highly purified form of Omega-3 Fatty Acids starting at 2-4 weeks after their ST Elevation Myocardial Infarction.They will need to take the drug for 9 months. Primary Outcome measure is sudden cardiac death .	Drug: Omega -3 fatty Acids Drug- Omega 3 fatty Acid , Route - Oral tablets, Dosage-4 gm/day , Start of Treatment- two to four weeks after STEMI, Duration of Treatment - 9 months
II: Placebo Comparator This arm will be given placebo instead of Omega-3 fatty acids . They will need to start taking this at 2 to 4 weeks post STEMI and for a duration of 9 months.	Drug: Placebo Placebo , Route- Oral tablets, Start of Treatment - two to four weeks after STEMI , Duration of Treatment - 9 Months

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All adults , >/= 21 years of age who suffer an ST Elevation Myocardial Infarction within the past two to four weeks , in the Greater Boston and adjacent regions (within a 50 mile radius)

Exclusion Criteria:

MRI contraindications such as metallic implants(pacemakers or AICD etc.)at time of study enrollment.
Active malignancy or any other terminal illness with an expected survival of less than 6 months
Significant renal dysfunction with GFR<60ml/min within 2 weeks of first MRI study
Inability to follow study protocol or inability to give consent
Pregnancy
Hemodynamic Instability
Urgent Clinical indication for Pacemaker or AICD
Inaccessibility of Medical Records

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729430

Contacts


Contact: Raymond Y Kwong, MD,MPH,FACC	857-307-1960	rykwong@partners.org

Contact: Mahadevan Rajaram, MD, FRCPC	857-307-1960	mrajaram@partners.org

Locations


United States, Massachusetts
	Brigham and Women's Hospital , Shapiro Cardiovascular Center	Recruiting
	Boston, Massachusetts, United States, 02115
	Contact: Raymond Y Kwong, MD, MPH, FACC 857-307-1960 rykwong@partners.org
	Contact: Mahadevan Rajaram, MD, FRCPC 857-307-1960 mrajaram@partners.org
	Principal Investigator: Raymond Y Kwong, MD,MPH,FACC
	Sub-Investigator: Mahadevan Rajaram, MD, FRCPC
	Sub-Investigator: Shuaib M Abdullah, MD

Sponsors and Collaborators

Brigham and Women's Hospital

GlaxoSmithKline

Investigators


Principal Investigator:	Raymond Y Kwong, MD,MPH,FACC	Brigham and Women's Hospital

More Information

Publications:

Yan AT, Shayne AJ, Brown KA, Gupta SN, Chan CW, Luu TM, Di Carli MF, Reynolds HG, Stevenson WG, Kwong RY. Characterization of the peri-infarct zone by contrast-enhanced cardiac magnetic resonance imaging is a powerful predictor of post-myocardial infarction mortality. Circulation. 2006 Jul 4;114(1):32-9. Epub 2006 Jun 26.

Responsible Party:	Brigham and Women's Hospital ( Raymond Y Kwong , MD, MPH . Director-Cardiac MRI )
Study ID Numbers:	1 R01 HL091157-01A1, 1R01HL091157-01A1
First Received:	August 4, 2008
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00729430
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Sudden Cardiac Death

Peri-infarct Zone on MRI

Fatty Acids , Omega-3

Prediction

Biological Markers

Cytogenetic Analysis

Study placed in the following topic categories:

Necrosis

Death

Heart Diseases

Myocardial Ischemia

Death, Sudden

Vascular Diseases

Heart Arrest

Ischemia

Death, Sudden, Cardiac

Infarction

Myocardial Infarction

Additional relevant MeSH terms:

Pathologic Processes

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	Brigham and Women's Hospital GlaxoSmithKline
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00729430