PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions

NCT00180466 | Completed DMC

• 1 other identifier: 04-800
• Study Type: observational
• Target: 697
• Locations: 12 countries
• Sites: 40

Brief Summary

PROSPECT is a multi-center prospective registry of Acute Coronary Syndromes (ACS) patients with single or double vessel coronary artery disease. Approximately 700 patients with ACS will be enrolled into the study at sites in the United States and European Union.

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Keywords

drug eluting stents; stents; angioplasty; coronary artery disease; total coronary occlusion; coronary artery restenosis; stent thrombosis; vascular disease; myocardial ischemia; coronary artery stenosis

Outcome Measures

Primary Outcomes (1)

• Primary outcome variable is Non-culprit Lesion Related Major Adverse Cardiac Events; defined as the composite of cardiac death, cardiac arrest, MI, ACS, revascularization by CABG, PCI, or rehospitalization by CABG or PCI or rehospitalization for angina

  Inhospital, 30 days, 180 days, 1 year and then yearly for up to 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting with an Acute Coronary Syndrome that require catheterization and interventional treatment of a culprit lesion(s).

You may qualify if:

• Acute cardiac pain, or angina equivalent, consistent with unstable angina or myocardial infarction, lasting greater than 10 minutes duration within the past 72 hours.
• Patient must have evidence of an ACS requiring catheterization documented by the presence of any one of the following conditions:
• Elevated enzymes (CK-MB or troponin I or troponin T greater than upper limits of normal).
• ST depression of \>1 mm in 2 or more contiguous leads measured at 40 ms after the J point, in the absence of left ventricular hypertrophy, bundle branch block, paced rhythms, pre-excitation or other ECG artifacts or confounding conditions.
• Transient ST elevation of \>1 mm in 2 or more contiguous leads lasting \<30 minutes (otherwise same criteria as above).
• ST elevation myocardial infarction with onset \>24 hours previously, diagnosed with the typical triad of nitrate unresponsive chest pain lasting \>30 minutes, ST elevation of \>1 mm in 2 or more contiguous leads or new left bundle branch block, and rise and fall of CK-MB isoenzymes.

You may not qualify if:

• Patient has had a documented acute ST-segment elevation myocardial infarction within the past 24 hours.
• Known serum creatinine \> 2.5 mg/dl.
• Decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or intraaortic balloon counterpulsation.
• Patient has a known hypersensitivity, allergy or contraindication to any of the following: aspirin, heparin, clopidogrel, and ticlopidine or to contrast that cannot be adequately pre-medicated.
• Presence of cardiac implants (i.e. implantable defibrillators); however, prior implantation of pacemaker or biventricular pacemaker is permitted.
• Presence of cardiogenic shock.
• Patient has a known left ventricular ejection fraction \<30%.
• Refractory ventricular arrhythmia requiring either intravenous pharmacologic treatment or defibrillator therapy (e.g. ventricular tachycardia or fibrillation).
• Acute conduction system disease requiring temporary pacemaker insertion.
• Patient has had a recent (within 6 months) PCI unless the patient is undergoing a staged procedure for dual vessel treatment.
• Patient has other medical illness (i.e., cancer or congestive heart failure) or recent history of substance abuse that may cause non-compliance with the Investigational Plan, confound the data interpretation or is associated with an anticipated limited life expectancy less than one year..
• Prior participation in this study or patient is currently enrolled in another investigational use device or drug study that has not reached its primary endpoint. If the patient is enrolled in another study that is not investigational, required visits for that trial must not interfere with the conduct of this trial.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (40)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Good Samaritan Hospital

San Jose, California, 95124, United States

Location

Stanford Hospital and Clinics

Stanford, California, 94305, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

St. Vincent's Hospital and Health Care Center

Indianapolis, Indiana, 46290, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 85006, United States

Location

Mt. Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

EMH Regional Medical Center

Elyria, Ohio, 44035, United States

Location

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, 17101, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Sisters of Charity Providence Hospitals

Columbia, South Carolina, 29204, United States

Location

St. Thomas Hospital

Nashville, Tennessee, 37205, United States

Location

OLV-Hospital Aalst

Aalst, Belgium

Location

A.Z. Middleheim

Antwerp, Belgium

Location

Skejby Sygehus

Aarhus, Denmark

Location

CHU Jean Minjoz

Besançon, France

Location

Clinique Pasteur

Toulouse, France

Location

Kerckhoff Klinik

Bad Nauheim, Germany

Location

Herzzentrum Klinik für Kardiologie

Bad Oeynhausen, Germany

Location

Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, Germany

Location

Azienda Ospedaliera S. Orsola-Malpighi

Bologna, Italy

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

University Hospital Krakow

Krakow, Poland

Location

Hospital Santa Cruz

Carnaxide, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

University Hospital Gregorio Maranon

Madrid, Spain

Location

Hospital do Meixoeiro

Vigo Pontevedra, Spain

Location

Sahlgrenska Sjukhuset

Gothenburg, Sweden

Location

University Hospital Zürich

Zurich, Switzerland

Location

The London Chest Hospital

London, United Kingdom

Location

Related Publications (25)

• Stone Gregg W, Lansky A.; Carlier S. et. al. A prospective, natural history study of multimodality invasive imaging to characterize vulnerable plaque: First report of the baseline findings from the PROSPECT trial. Journal of the American College of Cardiology 49(9, Suppl. B): p 19B MAR 6 2007.

  RESULT

• Ostuka Masato; Bruining N.; Van Pelt, N.; et.al. Three-dimensional quantification of coronary plaque burden by 64-slice computed tomography: A PROS-PECT-MSCT substudy. Journal of the American College of Cardiology 49(9, Suppl. A): p 114A MAR 6 2007

  RESULT

• Tanaka K; Carlier SG; Mintz GS; et.al. High risk fibroatheroma lesions are remote from the minimal lumen area site: A virtual histology IVUS analysis from the PROSPECT study AMERICAN JOURNAL OF CARDIOLOGY, 2006, V 98, N8A, P 94M-94M.

  RESULT

• Gu SZ, Ahmed ME, Huang Y, Hakim D, Maynard C, Cefalo NV, Coskun AU, Costopoulos C, Maehara A, Stone GW, Stone PH, Bennett MR. Comprehensive biomechanical and anatomical atherosclerotic plaque metrics predict major adverse cardiovascular events: A new tool for clinical decision making. Atherosclerosis. 2024 Mar;390:117449. doi: 10.1016/j.atherosclerosis.2024.117449. Epub 2024 Jan 11.

  PMID: 38262275 DERIVED

• Seike F, Mintz GS, Matsumura M, Ali ZA, Liu M, Jeremias A, Ben-Yehuda O, De Bruyne B, Serruys PW, Yasuda K, Stone GW, Maehara A. Impact of Intravascular Ultrasound-Derived Lesion-Specific Virtual Fractional Flow Reserve Predicts 3-Year Outcomes of Untreated Nonculprit Lesions: The PROSPECT Study. Circ Cardiovasc Interv. 2022 Nov;15(11):851-860. doi: 10.1161/CIRCINTERVENTIONS.121.011198. Epub 2022 Nov 15.

  PMID: 36378741 DERIVED

• Farhan S, Redfors B, Maehara A, McAndrew T, Ben-Yehuda O, De Bruyne B, Mehran R, Vogel B, Giustino G, Serruys PW, Mintz GS, Stone GW. Relationship between insulin resistance, coronary plaque, and clinical outcomes in patients with acute coronary syndromes: an analysis from the PROSPECT study. Cardiovasc Diabetol. 2021 Jan 7;20(1):10. doi: 10.1186/s12933-020-01207-0.

  PMID: 33413366 DERIVED

• Farhan S, Redfors B, Maehara A, McAndrew T, Ben-Yehuda O, De Bruyne B, Mehran R, Giustino G, Kirtane AJ, Serruys PW, Mintz GS, Stone GW. Impact of Pre-Diabetes on Coronary Plaque Composition and Clinical Outcome in Patients With Acute Coronary Syndromes: An Analysis From the PROSPECT Study. JACC Cardiovasc Imaging. 2019 Apr;12(4):733-741. doi: 10.1016/j.jcmg.2017.06.023. Epub 2017 Oct 18.

  PMID: 29055637 DERIVED

• Zheng B, Mintz GS, McPherson JA, De Bruyne B, Farhat NZ, Marso SP, Serruys PW, Stone GW, Maehara A. Predictors of Plaque Rupture Within Nonculprit Fibroatheromas in Patients With Acute Coronary Syndromes: The PROSPECT Study. JACC Cardiovasc Imaging. 2015 Oct;8(10):1180-1187. doi: 10.1016/j.jcmg.2015.06.014.

  PMID: 26481843 DERIVED

• Goto K, Mintz GS, Litherland C, Lansky AJ, Weisz G, McPherson JA, De Bruyne B, Serruys PW, Stone GW, Maehara A. Lumen Measurements From Quantitative Coronary Angiography and IVUS: A PROSPECT Substudy. JACC Cardiovasc Imaging. 2016 Aug;9(8):1011-3. doi: 10.1016/j.jcmg.2015.07.006. Epub 2015 Sep 9. No abstract available.

  PMID: 26363838 DERIVED

• Xie Y, Mintz GS, Yang J, Doi H, Iniguez A, Dangas GD, Serruys PW, McPherson JA, Wennerblom B, Xu K, Weisz G, Stone GW, Maehara A. Clinical outcome of nonculprit plaque ruptures in patients with acute coronary syndrome in the PROSPECT study. JACC Cardiovasc Imaging. 2014 Apr;7(4):397-405. doi: 10.1016/j.jcmg.2013.10.010. Epub 2014 Mar 13.

  PMID: 24631511 DERIVED

• Inaba S, Mintz GS, Farhat NZ, Fajadet J, Dudek D, Marzocchi A, Templin B, Weisz G, Xu K, de Bruyne B, Serruys PW, Stone GW, Maehara A. Impact of positive and negative lesion site remodeling on clinical outcomes: insights from PROSPECT. JACC Cardiovasc Imaging. 2014 Jan;7(1):70-8. doi: 10.1016/j.jcmg.2013.10.007.

  PMID: 24433710 DERIVED

• Dohi T, Mintz GS, McPherson JA, de Bruyne B, Farhat NZ, Lansky AJ, Mehran R, Weisz G, Xu K, Stone GW, Maehara A. Non-fibroatheroma lesion phenotype and long-term clinical outcomes: a substudy analysis from the PROSPECT study. JACC Cardiovasc Imaging. 2013 Aug;6(8):908-16. doi: 10.1016/j.jcmg.2013.04.008. Epub 2013 Jul 10.

  PMID: 23850249 DERIVED

• Golinvaux N, Maehara A, Mintz GS, Lansky AJ, McPherson J, Farhat N, Marso S, de Bruyne B, Serruys PW, Templin B, Cheong WF, Aaskar R, Fahy M, Mehran R, Leon M, Stone GW. An intravascular ultrasound appraisal of atherosclerotic plaque distribution in diseased coronary arteries. Am Heart J. 2012 Apr;163(4):624-31. doi: 10.1016/j.ahj.2011.07.031.

  PMID: 22520529 DERIVED

• Sanidas EA, Mintz GS, Maehara A, Cristea E, Wennerblom B, Iniguez A, Fajadet J, Fahy M, Dressler O, Weisz G, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys P, Stone GW. Adverse cardiovascular events arising from atherosclerotic lesions with and without angiographic disease progression. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S95-S105. doi: 10.1016/j.jcmg.2011.08.024.

  PMID: 22421236 DERIVED

• Brener SJ, Mintz GS, Cristea E, Weisz G, Maehara A, McPherson JA, Marso SP, Farhat N, Botker HE, Dressler O, Xu K, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys PW, Stone GW. Characteristics and clinical significance of angiographically mild lesions in acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S86-94. doi: 10.1016/j.jcmg.2011.12.007.

  PMID: 22421235 DERIVED

• McPherson JA, Maehara A, Weisz G, Mintz GS, Cristea E, Mehran R, Foster M, Verheye S, Rabbani L, Xu K, Fahy M, Templin B, Zhang Z, Lansky AJ, de Bruyne B, Serruys PW, Stone GW. Residual plaque burden in patients with acute coronary syndromes after successful percutaneous coronary intervention. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S76-85. doi: 10.1016/j.jcmg.2012.01.005.

  PMID: 22421234 DERIVED

• Lansky AJ, Ng VG, Maehara A, Weisz G, Lerman A, Mintz GS, De Bruyne B, Farhat N, Niess G, Jankovic I, Lazar D, Xu K, Fahy M, Serruys PW, Stone GW. Gender and the extent of coronary atherosclerosis, plaque composition, and clinical outcomes in acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S62-72. doi: 10.1016/j.jcmg.2012.02.003.

  PMID: 22421232 DERIVED

• Baber U, Stone GW, Weisz G, Moreno P, Dangas G, Maehara A, Mintz GS, Cristea E, Fahy M, Xu K, Lansky AJ, Wennerblom B, Mathey DG, Templin B, Zhang Z, Serruys PW, Mehran R. Coronary plaque composition, morphology, and outcomes in patients with and without chronic kidney disease presenting with acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S53-61. doi: 10.1016/j.jcmg.2011.12.008.

  PMID: 22421231 DERIVED

• Marso SP, Mercado N, Maehara A, Weisz G, Mintz GS, McPherson J, Schiele F, Dudek D, Fahy M, Xu K, Lansky A, Templin B, Zhang Z, de Bruyne B, Serruys PW, Stone GW. Plaque composition and clinical outcomes in acute coronary syndrome patients with metabolic syndrome or diabetes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S42-52. doi: 10.1016/j.jcmg.2012.01.008.

  PMID: 22421230 DERIVED

• Papadopoulou SL, Neefjes LA, Garcia-Garcia HM, Flu WJ, Rossi A, Dharampal AS, Kitslaar PH, Mollet NR, Veldhof S, Nieman K, Stone GW, Serruys PW, Krestin GP, de Feyter PJ. Natural history of coronary atherosclerosis by multislice computed tomography. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S28-37. doi: 10.1016/j.jcmg.2012.01.009.

  PMID: 22421228 DERIVED

• Brugaletta S, Garcia-Garcia HM, Serruys PW, Maehara A, Farooq V, Mintz GS, de Bruyne B, Marso SP, Verheye S, Dudek D, Hamm CW, Farhat N, Schiele F, McPherson J, Lerman A, Moreno PR, Wennerblom B, Fahy M, Templin B, Morel MA, van Es GA, Stone GW. Relationship between palpography and virtual histology in patients with acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S19-27. doi: 10.1016/j.jcmg.2011.02.026.

  PMID: 22421227 DERIVED

• Wykrzykowska JJ, Mintz GS, Garcia-Garcia HM, Maehara A, Fahy M, Xu K, Inguez A, Fajadet J, Lansky A, Templin B, Zhang Z, de Bruyne B, Weisz G, Serruys PW, Stone GW. Longitudinal distribution of plaque burden and necrotic core-rich plaques in nonculprit lesions of patients presenting with acute coronary syndromes. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S10-8. doi: 10.1016/j.jcmg.2012.01.006.

  PMID: 22421223 DERIVED

• Maehara A, Cristea E, Mintz GS, Lansky AJ, Dressler O, Biro S, Templin B, Virmani R, de Bruyne B, Serruys PW, Stone GW. Definitions and methodology for the grayscale and radiofrequency intravascular ultrasound and coronary angiographic analyses. JACC Cardiovasc Imaging. 2012 Mar;5(3 Suppl):S1-9. doi: 10.1016/j.jcmg.2011.11.019.

  PMID: 22421222 DERIVED

• Stone GW, Maehara A, Lansky AJ, de Bruyne B, Cristea E, Mintz GS, Mehran R, McPherson J, Farhat N, Marso SP, Parise H, Templin B, White R, Zhang Z, Serruys PW; PROSPECT Investigators. A prospective natural-history study of coronary atherosclerosis. N Engl J Med. 2011 Jan 20;364(3):226-35. doi: 10.1056/NEJMoa1002358.

  PMID: 21247313 DERIVED

• Oviedo C, Maehara A, Mintz GS, Araki H, Choi SY, Tsujita K, Kubo T, Doi H, Templin B, Lansky AJ, Dangas G, Leon MB, Mehran R, Tahk SJ, Stone GW, Ochiai M, Moses JW. Intravascular ultrasound classification of plaque distribution in left main coronary artery bifurcations: where is the plaque really located? Circ Cardiovasc Interv. 2010 Apr;3(2):105-12. doi: 10.1161/CIRCINTERVENTIONS.109.906016. Epub 2010 Mar 2.

  PMID: 20197513 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Aproximately 1 ML blood

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Vascular Diseases; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Gregg Stone, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Patrick Serruys, MD, PhD

  Thoraxcenter, Erasmus University, Rotterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• Bernard de Bruyne, MD

  Cardiovascular Center, OLV Hospital, Aalst, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: October 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 25, 2010

Record last verified: 2010-05

Locations

CH (1); PL (1); DK (1); DE (3); GB (1); NL (1); BE (2); FR (2); IT (1); US (22); ES (4); SE (1)