Measurement of Matrix Metalloproteinase Activation Post Myocardial Infarction

NCT00576121 | Withdrawn

• 1 other identifier: 0610001945
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to look at the measurement and prediction of changes in the heart following a heart attack.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• To predict left ventricular remodeling after myocardial infarction using serum matrix metalloproteinase measurement with Tl201 SPECT/CT hybrid imaging and MRI.

  1 day

Study Arms (3)

1

Left ventricular ejection fraction (LVEF) patients will be compared at two time-points, 2-5 days and 4 weeks after acute MI.

2

End-diastolic volume (LVEDV) patients will be compared at two time-points, 2-5 days and 4 weeks after acute MI.

3

End-systolic volume (LVESV) patients will be compared at two time-points, 2-5 days and 4 weeks after acute MI.

Eligibility Criteria

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

Study Population

Patients will be recruited by a physician referral into the study. Patients will be referred to the study by the cardiologist in the cardiac catheterization lab at Yale New Haven Hospital. Patient recruitment will be limited to patients who are English speakers. Informed consent will be obtained by Dr. Albert Sinusas, MD.

You may qualify if:

• Diagnosis of acute myocardial infarction characterized by (1) greater than 30 minutes of chest pain; (2) ST elevation in 2 contiguous leads greater than 2mV; and (3) elevated serum markers greater than three times the normal value.
• Males or females 18 years of age or older.
• Adequate intravenous access in one arm.
• Willing to comply with the requirements of the protocol.
• Provided written informed consent to participate in the study.

You may not qualify if:

• History of significant co-morbidity requiring hospitalization separate from acute myocardial infarction (i.e. metastatic cancer).
• History of/current structural heart disease.
• Arrhythmia
• History of previous myocardial infarction
• History of coronary revascularization
• Cardiogenic shock
• Hypotension
• Renal failure (creatinine \>2mg/dl) or hyperkalemia (serum potassium \> 5.5mg/dl)
• History of allergic reaction to gadolinium
• Contraindication to undergo MR imaging (pacemaker, metallic implants, etc)
• History of claustrophobia
• Pregnant or breast-feeding, or (if pre-menopausal), not practicing acceptable method of birth control.
• History of any other conditions, which in the judgment of the investigator, are likely to hinder or confuse study conduct or to pose a safety concern to the patient.
• Resting HR \>110
• Chronic tetracycline or doxycycline use

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Related Publications (26)

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Study Officials

• Albert J Sinusas, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 15, 2007
• First Posted: December 18, 2007
• Study Start: July 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2012
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

US (1)