Measurement of Matrix Metalloproteinase Activation Post Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00576121
First received: December 15, 2007
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

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


Condition
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Measurement of Matrix Metalloproteinase Activation Post Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • To predict left ventricular remodeling after myocardial infarction using serum matrix metalloproteinase measurement with Tl201 SPECT/CT hybrid imaging and MRI. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Ongoing/active rheumatic disease requiring significant anti-inflammatory agents, steroids or immunosuppression
  • Not capable of informed consent
  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: NCT00576121

Contacts
Contact: Carol Akirav, MSc 203-785-2429 carol.akirav@yale.edu
Contact: Albert J Sinusas, MD 203-785-3155 albert.sinusas@yale.edu

Locations
United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Carol Akirav, MSc    203-785-2429    carol.akirav@yale.edu   
Contact: Albert J Sinusas, MD    203-785-3155    albert.sinusas@yale.edu   
Sub-Investigator: Hamid Mojibian, MD         
Sub-Investigator: Daniel Cornfeld, MD         
Sub-Investigator: Gabriel Vorobiof, MD         
Sub-Investigator: Robert McNamara, MD         
Sub-Investigator: Farid Jadbabaie, MD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Albert J Sinusas, MD Yale University
  More Information

Publications:

Responsible Party: Dr. Albert Sinusas, Yale University
ClinicalTrials.gov Identifier: NCT00576121     History of Changes
Other Study ID Numbers: 0610001945
Study First Received: December 15, 2007
Last Updated: January 13, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014