Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Measurement of Matrix Metalloproteinase Activation Post Myocardial Infarction
This study is not yet open for participant recruitment.
Verified by Yale University, June 2008
Sponsored by: Yale University
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00576121
  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

MedlinePlus related topics: Heart Attack
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Prospective
Official Title: Measurement of Matrix Metalloproteinase Activation Post Myocardial Infarction

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
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
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
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Albert J Sinusas, MD Yale University
  More Information

Publications:
Lindsey ML. MMP induction and inhibition in myocardial infarction. Heart Fail Rev. 2004 Jan;9(1):7-19. Review.
Cohn JN, Ferrari R, Sharpe N. Cardiac remodeling--concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. Behalf of an International Forum on Cardiac Remodeling. J Am Coll Cardiol. 2000 Mar 1;35(3):569-82. Review.
Wilson EM, Moainie SL, Baskin JM, Lowry AS, Deschamps AM, Mukherjee R, Guy TS, St John-Sutton MG, Gorman JH 3rd, Edmunds LH Jr, Gorman RC, Spinale FG. Region- and type-specific induction of matrix metalloproteinases in post-myocardial infarction remodeling. Circulation. 2003 Jun 10;107(22):2857-63. Epub 2003 May 27.
Kai H, Ikeda H, Yasukawa H, Kai M, Seki Y, Kuwahara F, Ueno T, Sugi K, Imaizumi T. Peripheral blood levels of matrix metalloproteases-2 and -9 are elevated in patients with acute coronary syndromes. J Am Coll Cardiol. 1998 Aug;32(2):368-72.
Bradham WS, Gunasinghe H, Holder JR, Multani M, Killip D, Anderson M, Meyer D, Spencer WH 3rd, Torre-Amione G, Spinale FG. Release of matrix metalloproteinases following alcohol septal ablation in hypertrophic obstructive cardiomyopathy. J Am Coll Cardiol. 2002 Dec 18;40(12):2165-73.
Spinale FG. Matrix metalloproteinases: regulation and dysregulation in the failing heart. Circ Res. 2002 Mar 22;90(5):520-30. Review.
Mukherjee R, Brinsa TA, Dowdy KB, Scott AA, Baskin JM, Deschamps AM, Lowry AS, Escobar GP, Lucas DG, Yarbrough WM, Zile MR, Spinale FG. Myocardial infarct expansion and matrix metalloproteinase inhibition. Circulation. 2003 Feb 4;107(4):618-25.
Ducharme A, Frantz S, Aikawa M, Rabkin E, Lindsey M, Rohde LE, Schoen FJ, Kelly RA, Werb Z, Libby P, Lee RT. Targeted deletion of matrix metalloproteinase-9 attenuates left ventricular enlargement and collagen accumulation after experimental myocardial infarction. J Clin Invest. 2000 Jul;106(1):55-62.
Creemers EE, Davis JN, Parkhurst AM, Leenders P, Dowdy KB, Hapke E, Hauet AM, Escobar PG, Cleutjens JP, Smits JF, Daemen MJ, Zile MR, Spinale FG. Deficiency of TIMP-1 exacerbates LV remodeling after myocardial infarction in mice. Am J Physiol Heart Circ Physiol. 2003 Jan;284(1):H364-71. Epub 2002 Sep 26.
Lindsey ML, Escobar GP, Dobrucki LW, Goshorn DK, Bouges S, Mingoia JT, McClister DM Jr, Su H, Gannon J, MacGillivray C, Lee RT, Sinusas AJ, Spinale FG. Matrix metalloproteinase-9 gene deletion facilitates angiogenesis after myocardial infarction. Am J Physiol Heart Circ Physiol. 2006 Jan;290(1):H232-9. Epub 2005 Aug 26.
Su H, Spinale FG, Dobrucki LW, Song J, Hua J, Sweterlitsch S, Dione DP, Cavaliere P, Chow C, Bourke BN, Hu XY, Azure M, Yalamanchili P, Liu R, Cheesman EH, Robinson S, Edwards DS, Sinusas AJ. Noninvasive targeted imaging of matrix metalloproteinase activation in a murine model of postinfarction remodeling. Circulation. 2005 Nov 15;112(20):3157-67. Epub 2005 Nov 7.
Higo S, Uematsu M, Yamagishi M, Ishibashi-Ueda H, Awata M, Morozumi T, Ohara T, Nanto S, Nagata S. Elevation of plasma matrix metalloproteinase-9 in the culprit coronary artery in patients with acute myocardial infarction: clinical evidence from distal protection. Circ J. 2005 Oct;69(10):1180-5.
Hojo Y, Ikeda U, Katsuki T, Mizuno O, Fujikawa H, Shimada K. Matrix metalloproteinase expression in the coronary circulation induced by coronary angioplasty. Atherosclerosis. 2002 Mar;161(1):185-92.
Hojo Y, Ikeda U, Ueno S, Arakawa H, Shimada K. Expression of matrix metalloproteinases in patients with acute myocardial infarction. Jpn Circ J. 2001 Feb;65(2):71-5.
Sundstrom J, Evans JC, Benjamin EJ, Levy D, Larson MG, Sawyer DB, Siwik DA, Colucci WS, Sutherland P, Wilson PW, Vasan RS. Relations of plasma matrix metalloproteinase-9 to clinical cardiovascular risk factors and echocardiographic left ventricular measures: the Framingham Heart Study. Circulation. 2004 Jun 15;109(23):2850-6. Epub 2004 Jun 01.
Sundström J, Evans JC, Benjamin EJ, Levy D, Larson MG, Sawyer DB, Siwik DA, Colucci WS, Wilson PW, Vasan RS. Relations of plasma total TIMP-1 levels to cardiovascular risk factors and echocardiographic measures: the Framingham heart study. Eur Heart J. 2004 Sep;25(17):1509-16.
Kaden JJ, Dempfle CE, Sueselbeck T, Brueckmann M, Poerner TC, Haghi D, Haase KK, Borggrefe M. Time-dependent changes in the plasma concentration of matrix metalloproteinase 9 after acute myocardial infarction. Cardiology. 2003;99(3):140-4.
Webb CS, Bonnema DD, Ahmed SH, Leonardi AH, McClure CD, Clark LL, Stroud RE, Corn WC, Finklea L, Zile MR, Spinale FG. Specific temporal profile of matrix metalloproteinase release occurs in patients after myocardial infarction: relation to left ventricular remodeling. Circulation. 2006 Sep 5;114(10):1020-7. Epub 2006 Aug 21.
Choi JY, Moon DH, Lee CW, Shin JW, Park SW, Hong MK, Song JK, Park SJ, Lee HK. Prediction of left ventricular dilatation with thallium-201 SPET imaging after primary angioplasty in patients with acute myocardial infarction. Eur J Nucl Med Mol Imaging. 2002 Jun;29(6):728-34. Epub 2002 Apr 6.
Oudiz RJ, Smith DE, Pollak AJ, Mena I, Shapiro SM, Ginzton LE, Narahara KA. Nitrate-enhanced thallium 201 single-photon emission computed tomography imaging in hibernating myocardium. Am Heart J. 1999 Aug;138(2 Pt 1):369-75.
Watzinger N, Lund GK, Higgins CB, Wendland MF, Weinmann HJ, Saeed M. The potential of contrast-enhanced magnetic resonance imaging for predicting left ventricular remodeling. J Magn Reson Imaging. 2002 Dec;16(6):633-40.
Schroeder AP, Houlind K, Pedersen EM, Nielsen TT, Egeblad H. Serial magnetic resonance imaging of global and regional left ventricular remodeling during 1 year after acute myocardial infarction. Cardiology. 2001;96(2):106-14.
Wellnhofer E, Olariu A, Klein C, Gräfe M, Wahl A, Fleck E, Nagel E. Magnetic resonance low-dose dobutamine test is superior to SCAR quantification for the prediction of functional recovery. Circulation. 2004 May 11;109(18):2172-4. Epub 2004 Apr 26.
Hombach V, Grebe O, Merkle N, Waldenmaier S, Höher M, Kochs M, Wöhrle J, Kestler HA. Sequelae of acute myocardial infarction regarding cardiac structure and function and their prognostic significance as assessed by magnetic resonance imaging. Eur Heart J. 2005 Mar;26(6):549-57. Epub 2005 Feb 15.
Bucciarelli-Ducci C, Wu E, Lee DC, Holly TA, Klocke FJ, Bonow RO. Contrast-enhanced cardiac magnetic resonance in the evaluation of myocardial infarction and myocardial viability in patients with ischemic heart disease. Curr Probl Cardiol. 2006 Feb;31(2):128-68. Review. No abstract available.
Soejima H, Ogawa H, Sakamoto T, Miyamoto S, Kajiwara I, Kojima S, Hokamaki J, Sugiyama S, Yoshimura M, Suefuji H, Miyao Y, Fujimoto K, Miyagi H, Kishikawa H. Increased serum matrix metalloproteinase-1 concentration predicts advanced left ventricular remodeling in patients with acute myocardial infarction. Circ J. 2003 Apr;67(4):301-4.

Responsible Party: Yale University ( Dr. Albert Sinusas )
Study ID Numbers: 0610001945
Study First Received: December 15, 2007
Last Updated: June 13, 2008
ClinicalTrials.gov Identifier: NCT00576121  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009