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Cardiovascular
I - Acute Ischemic Coronary Syndromes Background The
pathology of acute ischemia is typically related to plaque instability,
thrombus formation, and coronary flow obstruction resulting in myocardial
damage. The intervention is
targeted to restore patency, whether through use of thrombolytic agents or
direct revascularization. The
relevant biomarker would be related to a patency and/or perfusion
assessment. Patency can be
assessed directly by angiography or indirectly by perfusion techniques. Moderators:
Victor Dzau, M.D., Brigham and Women’s Hospital
Judith Hochman, M.D., Columbia University College of Physicians and
Surgeons Agenda Targeted
Topics: Acute Myocardial Infarction, Acute Heart Failure, Unstable Angina Clinical
Trials Challenges David
L. DeMets, Ph.D., University of Wisconsin, Madison Angiography David
O. Williams, M.D., Brown University and Rhode Island Hospital Jeffrey
Popma, M.D., Brigham and Women’s Hospital Myocardial
Imaging Frans
Wackers, M.D., Yale School of Medicine Pamela
S. Douglas, M.D., Beth Israel Hospital Myocardial
Viability Nathaniel
Reichek, M.D., Medical College of Pennsylvania and MCP Hahnemann
University Robert
Bonow, M.D., Northwestern University Medical School Plaque Ward
Casscells, M.D., University of Texas Medical School and Hermann Hospital Zahi
Fayed, Ph.D., Mount Sinai School of Medicine Markers: ECG SerumBernard
R. Chaitman, M.D., St. Louis University Medical Center Allan
Jaffe, M.D., State University of New York Health Sciences Center, Syracuse Discussant:
Robert R. Fenichel, M.D., Ph.D., Center for Drug Evaluation and
Research, U.S. Food and Drug Administration ABSTRACTSAtherosclerotic Plaque Imaging by Magnetic Resonance
Imaging Zahi
A. Fayad, Ph.D., and Valentin Fuster, M.D., Ph.D. There
has been increasing focus on the importance of the composition of
atherosclerotic plaque, rather than the degree of luminal narrowing, as
the major risk factor for acute coronary syndromes. However, current imaging modalities are limited at evaluating
the wall and characterization of the plaque.
Magnetic resonance imaging (MRI) methods are currently being
employed to noninvasively characterize the arterial wall and the
"vulnerable" atherosclerotic plaque in vivo.
We are using in vivo MRI to characterize carotid arteries and
aortic plaques in patients. New
techniques for coronary artery wall imaging and plaque characterization
are being tested. These
techniques also have been adapted for the study of plaques in different
animal models. For example, we have recently demonstrated that MRI can
characterize plaques in apolioprotein E knockout mice using in vivo
magnetic resonance microscopy. We
can follow in vivo progression, regression, and plaque stabilization in
these animal models. These
methods will allow the study of the pathogenesis of atherosclerotic
plaques, as well as the influence of genetics or drugs on plaque
development. In patients,
successful application of these methods should allow the early
identification of the "vulnerable" plaques.
This opens up whole new areas for diagnosis, prevention, and
treatment (e.g., lipid-lowering drug regimens). Key
References Fayad
ZA, Fallon JT, Shinnar M, Wehrli S, Dansky HM, Poon M, Badimon JJ,
Charlton SA, Fisher EA, Breslow JL, Fuster V. Noninvasive in vivo
high-resolution magnetic resonance imaging of atherosclerotic lesions in
genetically engineered mice. Circulation 1998;98:1541‑1547. Fayad
ZA, Tamana N, Badimon JJ, Goldman M, Weinberger J, Fallon JT, Aguinaldo G,
Shinnar M, Chesebro JH, Fuster V. Circulation 1998;98;1‑515. Fuster
V, Badimon L, Badimon JJ, Chesebro JH. The pathogenesis of coronary artery
disease and the acute coronary syndromes (2). N Engl J Med 1992;
326:242‑250 (part 1) and 310‑318 (part 2). Fuster
V, Fallon JT, Badimon JJ, Nemerson Y. The unstable atherosclerotic plaque:
clinical significance and therapeutic intervention. Thrombosis Haemostasis
1997; 78:247‑255. Shinnar
M, Fayad ZA, Fallon JT, Fuster V. in Fuster V., eds. The Vulnerable
Atherosclerotic Plaque: Understanding, Idenfication, and Modification,
Armonk, NY: Futura Publishing, 1999, pp.155‑162. Toussaint
JF, LaMuraglia GM, Southern JF, Fuster V, Kantor HL. Magnetic resonance
images lipid, fibrous, calcified, hemorrhagic, and thrombotic components
of human atherosclerosis in vivo. Circulation 1996;94:932‑938. Vallabahajosula
S, Fuster VJ. Nucl Med 1997;38:1788‑1796. Myocardial Viability Nathaniel
Reichek, M.D. A
variety of potential cardiac imaging biomarkers are available for
assessment of myocardial viability in acute and chronic ischemic heart
disease. These include
positron emission tomography for assessment of myocardial perfusion and
metabolism; single photon emission computerized tomography imaging using
thallium 201; and dobutamine wall motion studies using echocardiography,
magnetic resonance imaging, or computerized tomography.
Additional candidate approaches include contrast echocardiography,
proton MRI contrast imaging and tissue tagging, 31P NMR
spectroscopy, sodium MRI, and proton MRI to detect myocardial production
of O17 water. However, none
of these approaches permits rigorous quantitation of the amount of viable
myocardium routinely in humans. Lack of reliable transmural resolution of necrotic versus
viable myocardium is a particular problem.
Although the general relationship between salvage of myocardium and
clinical outcomes is well described, no simple algorithms exist to permit
quantitative extrapolation from any viability biomarkers to affect
clinical outcome. It is also
unclear in acute myocardial infarction whether the characteristics and
outcome of viable myocardium generated by various reperfusion strategies
are similar or different. Finally,
the ultimate fate of viable myocardium is also determined by vascular
outcomes that cannot be assessed by viability biomarkers, such as
thrombotic reocclusion, restenosis, and bypass graft closure. Key
References Baumgartner
H, Porenta G, Lau YK, Wutte M, Klaar U, Mehrabi M, Siegel RJ, Czernin J,
Laufer G, Sochor H, Schelbert H, Fishbein MC, Maurer G. Assessment of
myocardial viability by dobutamine echocardiography, positron emission
tomography and thallium‑201 SPECT: Correlation with histopathology
in explanted hearts. J Am Coll Cardiol 1998 Nov15;32(6):1701‑1708. Beller
GA, Ragosta M. Extent of myocardial viability in regions of left
ventricular dysfunction by rest‑redistribution thallium‑201
imaging: A powerful predictor of outcome. J Nucl Cardiol
1998;5:445‑448. Bonow
RO. Identification of viable myocardium. Circulation
1996;94:2674‑2680. Geskin
G, Kramer CM, Rogers WJ, Theobald TM, Pakstis D, Hu Y‑L, Reichek N.
Quantitative assessment of myocardial viability post‑infarction by
dobutamine magnetic resonance tagging. Circulation 1998;98:217‑223. Grandin
C, Wijns W, Melin JA, Bol A, Robert AR, Heyndrickx GR, Michel C,
Vanoverschelde JL. Delineation of myocardial viability with PET. J Nucl
Med 1995;36:1543‑1552. Kloner
RA, Bolli R, Marban E, Reinlib L, Braunwald E. Medical and cellular
implications of stunning, hibernation and preconditioning. An NHLBI
Workshop. Circulation 1998;97:1848‑1867. Rogers
WJ, Kramer CM, Geskin G, Hu YL, Theobald TM, Vido DA, Petruolo S, Reichek
N. Early contrast‑enhanced MRI predicts late functional recovery
after reperfused myocardial infarction. Circulation 1999;99:744‑751. Smart
SC, Sawada S, Ryan T, Segar D, Atherton L, Berkovitz K, Bourdillon PDV,
Feigenbaum H. Low‑dose dobutamine echocardiography detects
reversible dysfunction after thrombolytic therapy of acute myocardial
infarction. Circulation 1993;88:405‑415. Tillisch
J, Brunken R, Marshall R, Schwaiger M, Mandelkern M, Phelps M, Schelbert
H. Reversibility of cardiac wall‑motion abnormalities predicted by
positron tomography. N Engl J Med 1986;314:884. Echocardiography in Acute Coronary Syndromes Pamela
S. Douglas, M.D. Cardiac
echocardiography is an important part of the management of acute coronary
syndromes, and much research has gone into identifying prognostic
features. Echocardiography is
therefore a useful tool in risk stratification, with high‑quality
research indicating excess mortality in patients with lower global left
ventricular function (ejection fraction), more extensive regional
abnormalities, moderate or severe mitral valve regurgitation and acute
left ventricular dilation, and longer term remodeling.
Unfortunately, such studies have wide confidence intervals; few
analyses have been done to determine the predictive power of these
variables for cardiac events or death; and no studies have yet
demonstrated causal relationships between echocardiographic findings and
subsequent events. A
promising echocardiographic tool, myocardial perfusion assessment by the
use of intravenous microbubble injection, is currently in development.
Only one multicenter assessment of test performance has been
reported, indicating poor sensitivity for segmental perfusion defects
(compared with single photon emission computerized tomography sestamibi),
with reasonable specificity. This
technique is not yet sufficiently refined to replace angiography in
determining coronary patency. Key
References DeMaria
AN, Cotter B, Ohmori K. Myocardial contrast echocardiography: Too much,
too soon? (editorial) J Am Coll Cardiol 1998;32(5):1270‑1271. Lehmann
KG, Francis CK, Dodge HT. Mitral regurgitation in early myocardial
infarction. Incidence, clinical detection, and prognostic implications.
TIMI Study Group. Ann Intern Med 1992;117(1):10‑17. Marwick
TH, Brunken R, Meland N, Brochet E, Baer FM, Binder T, Flachskampf F, Kamp
O, Nienaber C, Nihoyannopoulos P, Pierard L, Vanoverschelde JL, van der
Wouw P, Lindvall K. Accuracy and feasibility of contrast echocardiography
for detection of perfusion defects in routine practice: Comparison with
wall motion and technetium‑99m sestamibi single‑photon
emission computed tomography. The Nycomed NC100100 Investigators. J Am
Coll Cardiol 1998;32(5):1260‑1269. Popovic
AD, Neskovic AN, Marinkovic J, Thomas JD. Acute and long‑term
effects of thrombolysis after anterior wall acute myocardial infarction
with serial assessment of infarct expansion and late ventricular
remodeling. Am J Cardiol 1996;77(7):446‑450. St.
John Sutton M, Pfeffer MA, Plappert T, Rouleau JL, Moye LA, Dagenais GR,
Lamas GA, Klein M, Sussex B, Goldman S, et al. Quantitative
two‑dimensional echocardiographic measurements are major predictors
of adverse cardiovascular events after acute myocardial infarction. The
protective effects of captopril. Circulation 1994;89(1):68‑75. Volpi
A, De Vita C, Franzosi MG, Geraci E, Maggioni AP, Mauri F, Negri E,
Santoro E, Tavazzi L, Tognoni G. Determinants of 6‑month mortality
in survivors of myocardial infarction after thrombolysis. Results of the
GISSI‑2 data base. The Ad hoc Working Group of the Gruppo Italiano
per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI)‑2
Data Base. Circulation 1993;88(2):416‑429. Acute Ischemic Coronary Syndromes:
Electrocardiogram Bernard
R. Chaitman, M.D. and Allan S. Jaffe, M.D. In
clinical trials, sample size can be reduced by identifying high‑risk
patient subsets at entry. The
magnitude of risk can be related to clinical characteristics and the
extent of electrocardiographic (ECG) abnormalities.
Novel lead configurations, more frequent ECG acquisition, and use
of selected coding criteria have the potential to further enhance
identification. Definitions
of Q or non‑Q wave myocardial infarction vary considerably in trials
of acute coronary syndrome (ACS). Cardiac
serum markers (i.e., serial CK‑MB and cardiac troponins) identify
the presence of myocyte injury. Appropriate
cutpoints for the definition of myocardial infarction have become
problematic of late with the advent of more sensitive markers, especially
in patients with heart failure and hypertension and those after
interventional and cardiac surgical procedures.
Sampling frequency, the type of assay used, missing samples, and
determination of myocardial infarction represent challenges to clinical
trial design. Estimates of
myocardial infarction size have been considered as a surrogate endpoint
for mortality, enhancing the specificity of this composite endpoint, but
have become more problematic in the area of recanalization.
Myocardial infarction definitions in clinical trials of ACS will
undoubtedly represent tradeoffs between sensitivity versus specificity.
Standardized definitions should be used for reporting purposes and
comparability among studies. |