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
Recruitment status was Recruiting
Sponsor:
Yale University
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00576121
First received: December 15, 2007
Last updated: January 13, 2010
Last verified: January 2010
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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.
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|
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.
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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
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 June 18, 2013