Non-invasive cardiac assessment in high risk patients (The GROUND study): Rationale, objectives and design of a multi-center randomized controlled clinical trial

Trials

Volumn 9, Issue , 2008, Pages

  de Vos, Alexander M ^a   Rutten, Annemarieke ^a   van de Zaag Loonen, Hester J ^b   Bots, Michiel L ^a   Dikkers, Riksta ^b   Buiskool, Robert A ^c   Mali, Willem P ^a   Lubbers, Daniel D ^b   Mosterd, Arend ^c   Prokop, Mathias ^a   Rensing, Benno J ^d   Cramer, Maarten J ^a   van Es, H Wouter ^d   Moll, Frans L ^a   van de Pavoordt, Eric D ^d   Doevendans, Pieter A ^a   Velthuis, Birgitta K ^a   Mackaay, Albert J ^c   Zijlstra, Felix ^b   Oudkerk, Matthijs ^b  

^a UNIVERSITY MEDICAL CENTER UTRECHT   (Netherlands)

^b UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^c MEANDER MEDICAL CENTER   (Netherlands)

^d ST ANTONIUS HOSPITAL   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTIHYPERTENSIVE AGENT; DOBUTAMINE; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; METOPROLOL;

ADULT; ARTICLE; CARDIOVASCULAR DISEASE; CLINICAL PROTOCOL; CLINICAL TRIAL; COMPUTED TOMOGRAPHIC ANGIOGRAPHY; COMPUTER ASSISTED TOMOGRAPHY; CONTRAST ENHANCEMENT; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY BYPASS SURGERY; CORONARY ARTERY DISEASE; CORONARY ARTERY OBSTRUCTION; DRUG DOSE INCREASE; EVIDENCE BASED MEDICINE; FOLLOW UP; HEART MUSCLE ISCHEMIA; HIGH RISK PATIENT; HUMAN; LEFT CORONARY ARTERY; MAJOR CLINICAL STUDY; MULTICENTER STUDY; MULTIDETECTOR COMPUTED TOMOGRAPHY; NON INVASIVE MEASUREMENT; NUCLEAR MAGNETIC RESONANCE IMAGING; PERCUTANEOUS CORONARY INTERVENTION; PERIPHERAL OCCLUSIVE ARTERY DISEASE; PHARMACOLOGIC STRESS TESTING; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; SAMPLE SIZE; SCORING SYSTEM;

EID: 50849092933     PISSN: 17456215     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-9-49     Document Type: Article

References (45)

1. Kannel WB Skinner JJ Jr. Schwartz MJ Shurtleff D Intermittent claudication. Incidence in the Framingham Study Circulation 1970, 41:875-883 5444530
2. Murabito JM Evans JC Nieto K Larson MG Levy D Wilson PW Prevalence and clinical correlates of peripheral arterial disease in the Framingham Offspring Study Am Heart J 2002, 143:961-965 10.1067/mhj.2002.122871 12075249
3. Fowkes FG Housley E Cawood EH Macintyre CC Ruckley CV Prescott RJ Edinburgh Artery Study: Prevalence of asymptomatic and symptomatic peripheral arterial disease in the general population Int J Epidemiol 1991, 20:384-392 10.1093/ije/20.2.384 1917239
4. Weitz JI Byrne J Clagett GP Farkouh ME Porter JM Sackett DL Strandness DE Jr. Taylor LM Diagnosis and treatment of chronic arterial insufficiency of the lower extremities: A critical review Circulation 1996, 94:3026-3049 8941154
5. Coffman JD Intermittent claudication: Not so benign Am Heart J 1986, 112:1127-1128 10.1016/0002-8703(86)90339-X 3776816
6. Leng GC Lee AJ Fowkes FG Whiteman M Dunbar J Housley E Ruckley CV Incidence, natural history and cardiovascular events in symptomatic and asymptomatic peripheral arterial disease in the general population Int J Epidemiol 1996, 25:1172-1181 10.1093/ije/25.6.1172 9027521
7. Criqui MH Langer RD Fronek A Feigelson HS Klauber MR McCann TJ Browner D Mortality over a period of 10 years in patients with peripheral arterial disease N Engl J Med 1992, 326:381-386 1729621
8. Fiotti N Altamura N Cappelli C Schillan M Guarnieri G Giansante C Long term prognosis in patients with peripheral arterial disease treated with antiplatelet agents Eur J Vasc Endovasc Surg 2003, 26:374-380 10.1016/ S1078-5884(03)00318-6 14511998
9. Smith GD Shipley MJ Rose G Intermittent claudication, heart disease risk factors, and mortality. The Whitehall Study Circulation 1990, 82:1925-1931 2242518
10. Sonecha TN Delis KT Prevalence and distribution of coronary disease in claudicants using 12-lead precordial stress electrocardiography Eur J Vasc Endovasc Surg 2003, 25:519-526 10.1053/ejvs.2002.1902 12787693
11. Aronow WS Ahn C Prevalence of coexistence of coronary artery disease, peripheral arterial disease, and atherothrombotic brain infarction in men and women > or = 62 years of age Am J Cardiol 1994, 74:64-65 10.1016/0002-9149(94)90493-6 8017309
12. Hertzer NR Beven EG Young JR O'Hara PJ Ruschhaupt WF III Graor RA Dewolfe VG Maljovec LC Coronary artery disease in peripheral vascular patients. A classification of 1000 coronary angiograms and results of surgical management Ann Surg 1984, 199:223-233 1353337 6696538 10.1097/ 00000658-198402000-00016
13. de Bono D Complications of diagnostic cardiac catheterisation: Results from 34,041 patients in the United Kingdom confidential enquiry into cardiac catheter complications. The Joint Audit Committee of the British Cardiac Society and Royal College of Physicians of London Br Heart J 1993, 70:297-300 1025320 8398509 10.1136/hrt.70.3.297
14. Laskey W Boyle J Johnson LW Multivariable model for prediction of risk of significant complication during diagnostic cardiac catheterization. The Registry Committee of the Society for Cardiac Angiography & Interventions Cathet Cardiovasc Diagn 1993, 30:185-190 10.1002/ ccd.1810300302 8269487
15. Papaconstantinou HD Marshall AJ Burrell CJ Diagnostic cardiac catheterisation in a hospital without on-site cardiac surgery Heart 1999, 81:465-469 1729033 10212162
16. Prokop WM Galanski M Molen vd AJ Schaefer-Prokop C Spiral and Multislice Computed Tomography of the Body Thieme 2003.
17. Nieman K Oudkerk M Rensing BJ van Ooijen P Munne A van Geuns RJ de Feyter PJ Coronary angiography with multi-slice computed tomography Lancet 2001, 357:599-603 10.1016/S0140-6736(00)04058-7 11558487
18. Hoffmann MH Shi H Schmitz BL Schmid FT Lieberknecht M Schulze R Ludwig B Kroschel U Jahnke N Haerer W Brambs HJ Aschoff AJ Noninvasive coronary angiography with multislice computed tomography JAMA 2005, 293:2471-2478 10.1001/jama.293.20.2471 15914747
19. Mollet NR Cademartiri F van Mieghem CA Runza G McFadden EP Baks T Serruys PW Krestin GP de Feyter PJ High-resolution spiral computed tomography coronary angiography in patients referred for diagnostic conventional coronary angiography Circulation 2005, 112:2318-2323 10.1161/CIRCULATIONAHA.105.533471 16203914
20. Schroeder S Kopp AF Baumbach A Meisner C Kuettner A Georg C Ohnesorge B Herdeg C Claussen CD Karsch KR Noninvasive detection and evaluation of atherosclerotic coronary plaques with multislice computed tomography J Am Coll Cardiol 2001, 37:1430-1435 10.1016/S0735-1097(01)01115-9 11300457
21. Naghavi M Libby P Falk E Casscells SW Litovsky S Rumberger J Badimon JJ Stefanadis C Moreno P Pasterkamp G Fayad Z Stone PH Waxman S Raggi P Madjid M Zarrabi A Burke A Yuan C Fitzgerald PJ Siscovick DS de Korte CL Aikawa M Juhani Airaksinen KE Assmann G Becker CR Chesebro JH Farb A Galis ZS Jackson C Jang IK Koenig W Lodder RA March K Demirovic J Navab M Priori SG Rekhter MD Bahr R Grundy SM Mehran R Colombo A Boerwinkle E Ballantyne C Insull W Jr. Schwartz RS Vogel R Serruys PW Hansson GK Faxon DP Kaul S Drexler H Greenland P Muller JE Virmani R Ridker PM Zipes DP Shah PK Willerson JT From vulnerable plaque to vulnerable patient: A call for new definitions and risk assessment strategies: Part I Circulation 2003, 108:1664-1672 10.1161/01.CIR.0000087480.94275.97 14530185
22. Pennell DJ Underwood SR Manzara CC Swanton RH Walker JM Ell PJ Longmore DB Magnetic resonance imaging during dobutamine stress in coronary artery disease Am J Cardiol 1992, 70:34-40 10.1016/0002-9149(92)91386-I 1615867
23. Nagel E Lehmkuhl HB Bocksch W Klein C Vogel U Frantz E Ellmer A Dreysse S Fleck E Noninvasive diagnosis of ischemia-induced wall motion abnormalities with the use of high-dose dobutamine stress MRI: comparison with dobutamine stress echocardiography Circulation 1999, 99:763-770 9989961
24. Hundley WG Morgan TM Neagle CM Hamilton CA Rerkpattanapipat P Link KM Magnetic resonance imaging determination of cardiac prognosis Circulation 2002, 106:2328-2333 10.1161/01.CIR.0000036017.46437.02 12403662
25. Hundley WG Hamilton CA Thomas MS Herrington DM Salido TB Kitzman DW Little WC Link KM Utility of fast cine magnetic resonance imaging and display for the detection of myocardial ischemia in patients not well suited for second harmonic stress echocardiography Circulation 1999, 100:1697-1702 10525488
26. Kuijpers D Ho KY van Dijkman PR Vliegenthart R Oudkerk M Dobutamine cardiovascular magnetic resonance for the detection of myocardial ischemia with the use of myocardial tagging Circulation 2003, 107:1592-1597 10.1161/01.CIR.0000060544.41744.7C 12668491
27. Wahl A Paetsch I Roethemeyer S Klein C Fleck E Nagel E High-dose dobutamine-atropine stress cardiovascular MR imaging after coronary revascularization in patients with wall motion abnormalities at rest Radiology 2004, 233:210-216 10.1148/radiol.2331030463 15304662
28. Kuijpers D Janssen CH van Dijkman PR Oudkerk M Dobutamine stress MRI. Part I. Safety and feasibility of dobutamine cardiovascular magnetic resonance in patients suspected of myocardial ischemia Eur Radiol 2004, 14:1823-1828 15278415
29. Wellnhofer E Olariu A Klein C Grafe 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, 109:2172-2174 10.1161/01.CIR.0000128862.34201.74 15117834
30. van Dijkman PR Kuijpers DA Blom BM van Herpen G Dobutamine stress magnetic resonance imaging: A valuable method in the noninvasive diagnosis of ischemic heart disease J Electrocardiol 2002, 35 Suppl:57-9.:57-59 10.1054/jelc.2002.37155
31. Kuijpers D van Dijkman PR Janssen CH Vliegenthart R Zijlstra F Oudkerk M Dobutamine stress MRI. Part II. Risk stratification with dobutamine cardiovascular magnetic resonance in patients suspected of myocardial ischemia Eur Radiol 2004, 14:2046-2052 10.1007/s00330-004-2426-x 15278416
32. Paetsch I Jahnke C Wahl A Gebker R Neuss M Fleck E Nagel E Comparison of dobutamine stress magnetic resonance, adenosine stress magnetic resonance, and adenosine stress magnetic resonance perfusion Circulation 2004, 110:835-842 10.1161/01.CIR.0000138927.00357.FB 15289384
33. Smith SC Jr. Blair SN Bonow RO Brass LM Cerqueira MD Dracup K Fuster V Gotto A Grundy SM Miller NH Jacobs A Jones D Krauss RM Mosca L Ockene I Pasternak RC Pearson T Pfeffer MA Starke RD Taubert KA AHA/ACC Scientific Statement: AHA/ACC guidelines for preventing heart attack and death in patients with atherosclerotic cardiovascular disease: 2001 update: A statement for healthcare professionals from the American Heart Association and the American College of Cardiology Circulation 2001, 104:1577-1579 10.1161/hc3801.097475 11571256
34. Elhendy A Schinkel AF van Domburg RT Bax JJ Poldermans D Comparison of late outcome in patients with versus without angina pectoris having reversible perfusion abnormalities during dobutamine stress technetium-99m sestamibi single-photon emission computed tomography Am J Cardiol 2003, 91:264-268 10.1016/S0002-9149(02)03152-1 12565080
35. Pepine CJ Bourassa MG Chaitman BR Davies RF Kerensky RA Sharaf B Knatterud GL Forman SA Pratt CM Staples ED Sopko G Conti CR Factors influencing clinical outcomes after revascularization in the asymptomatic cardiac ischemia pilot (ACIP). ACIP Study Group J Card Surg 1999, 14:1-8 10.1111/j.1540-8191.1999.tb00943.x 10678439
36. Mooss AN Hilleman DE Mohiuddin SM Treatment of asymptomatic myocardial ischemia South Med J 1999, 92:967-970 10548168
37. Eagle KA Guyton RA Davidoff R Ewy GA Fonger J Gardner TJ Gott JP Herrmann HC Marlow RA Nugent WC O'Connor GT Orszulak TA Rieselbach RE Winters WL Yusuf S Gibbons RJ Alpert JS Eagle KA Garson A Jr. Gregoratos G Russell RO Smith SC Jr. ACC/AHA Guidelines for Coronary Artery Bypass Graft Surgery: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1991 Guidelines for Coronary Artery Bypass Graft Surgery). American College of Cardiology/American Heart Association J Am Coll Cardiol 1999, 34:1262-1347 10.1016/S0735-1097(99)00389-7 10520819
38. Boomsma LJ Bartelink ML Stoffers HE Wiersma T Assendelft WJ [Summary of the practice guideline 'Peripheral vascular disease' (first revision) from the Dutch College of General Practitioners] Ned Tijdschr Geneeskd 2004, 148:1490-1494 15481572
39. Henry WL DeMaria A Gramiak R King DL Kisslo JA Popp RL Sahn DJ Schiller NB Tajik A Teichholz LE Weyman AE Report of the American Society of Echocardiography Committee on Nomenclature and Standards in Two-dimensional Echocardiography Circulation 1980, 62:212-217 7397962
40. Aaronson NK Muller M Cohen PD Essink-Bot ML Fekkes M Sanderman R Sprangers MA te VA Verrips E Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations J Clin Epidemiol 1998, 51:1055-1068 10.1016/ S0895-4356(98)00097-3 9817123
41. Simons PC Algra A van de Laak MF Grobbee DE van der Graaf Y Second manifestations of ARTerial disease (SMART) study: Rationale and design Eur J Epidemiol 1999, 15:773-781 10.1023/A:1007621514757 10608355
42. Klein WM van der Graaf Y Seegers J Moll FL Mali WP Long-term cardiovascular morbidity, mortality, and reintervention after endovascular treatment in patients with iliac artery disease: The Dutch Iliac Stent Trial Study Radiology 2004, 232:491-498 10.1148/ radiol.2322030725 15286319
43. van der Tweel I Schipper M [Sequential analysis in clinical and epidemiological research] Ned Tijdschr Geneeskd 2002, 146:2348-2352 12510397
44. J W The design and analysis of sequential clinical trials. John Wiley & Sons revised 2nd edition 1997
45. unit MPS PEST 4: Operating manual The University of Reading 2000