PROSPECT: An Imaging Study in Patients With Unstable Atherosclerotic Lesions

NCT ID: NCT00180466

Last Updated: 2010-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 697 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2009-07-31

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.

Detailed Description

To identify in patients presenting with ACS imaging modalities and/or serologic markers of inflammation which may aid in the identification of non-flow obstructing lesions with an increased risk for future acute coronary events. This study will ascertain the prevalence and clinical significance of non-flow obstructing lesions, which subsequently result in acute coronary events - defined as vulnerable plaque. The safety of regional imaging of non-culprit lesions in ACS patients will also be assessed.

Conditions

Coronary Disease; Coronary Artery Disease; Coronary Restenosis

Study Design

• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Acute cardiac pain, or angina equivalent, consistent with unstable angina or myocardial infarction, lasting greater than 10 minutes duration within the past 72 hours.

2. Patient must have evidence of an ACS requiring catheterization documented by the presence of any one of the following conditions:

1. Elevated enzymes (CK-MB or troponin I or troponin T greater than upper limits of normal).

2. 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.

3. Transient ST elevation of >1 mm in 2 or more contiguous leads lasting <30 minutes (otherwise same criteria as above).

4. 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.

Exclusion Criteria

1. Patient has had a documented acute ST-segment elevation myocardial infarction within the past 24 hours.

2. Known serum creatinine > 2.5 mg/dl.

3. Decompensated hypotension or heart failure requiring intubation, inotropes, intravenous diuretics or intraaortic balloon counterpulsation.

4. 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.

5. Presence of cardiac implants (i.e. implantable defibrillators); however, prior implantation of pacemaker or biventricular pacemaker is permitted.

6. Presence of cardiogenic shock.

7. Patient has a known left ventricular ejection fraction <30%.

8. Refractory ventricular arrhythmia requiring either intravenous pharmacologic treatment or defibrillator therapy (e.g. ventricular tachycardia or fibrillation).

9. Acute conduction system disease requiring temporary pacemaker insertion.

10. Patient has had a recent (within 6 months) PCI unless the patient is undergoing a staged procedure for dual vessel treatment.

11. 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..

12. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott Vascular

Principal Investigators

Gregg Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Patrick Serruys, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Thoraxcenter, Erasmus University, Rotterdam, The Netherlands

Bernard de Bruyne, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Center, OLV Hospital, Aalst, Belgium

Locations

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Good Samaritan Hospital

San Jose, California, United States

Stanford Hospital and Clinics

Stanford, California, United States

Washington Hospital Center

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

Piedmont Hospital

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

St. Vincent's Hospital and Health Care Center

Indianapolis, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

St. Luke's Hospital

Kansas City, Missouri, United States

Mt. Sinai Hospital

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Presbyterian Hospital

Charlotte, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

EMH Regional Medical Center

Elyria, Ohio, United States

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Sisters of Charity Providence Hospitals

Columbia, South Carolina, United States

St. Thomas Hospital

Nashville, Tennessee, United States

OLV-Hospital Aalst

Aalst, , Belgium

A.Z. Middleheim

Antwerp, , Belgium

Skejby Sygehus

Aarhus, , Denmark

CHU Jean Minjoz

Besançon, , France

Clinique Pasteur

Toulouse, , France

Kerckhoff Klinik

Bad Nauheim, , Germany

Herzzentrum Klinik für Kardiologie

Bad Oeynhausen, , Germany

Universitäres Herz- und Gefäßzentrum Hamburg

Hamburg, , Germany

Azienda Ospedaliera S. Orsola-Malpighi

Bologna, , Italy

Erasmus Medical Center

Rotterdam, , Netherlands

University Hospital Krakow

Krakow, , Poland

Hospital Santa Cruz

Carnaxide, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

University Hospital Gregorio Maranon

Madrid, , Spain

Hospital do Meixoeiro

Vigo Pontevedra, , Spain

Sahlgrenska Sjukhuset

Gothenburg, , Sweden

University Hospital Zürich

Zurich, , Switzerland

The London Chest Hospital

London, , United Kingdom

Countries

United States; Belgium; Denmark; France; Germany; Italy; Netherlands; Poland; Spain; Sweden; Switzerland; United Kingdom

References

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.

Reference Type: 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

Reference Type: 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.

Reference Type: 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.

Reference Type: DERIVED

PMID: 38262275 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36378741 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33413366 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29055637 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26481843 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26363838 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24631511 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24433710 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23850249 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22520529 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421236 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421235 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421234 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421232 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421231 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421230 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421228 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421227 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421223 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22421222 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21247313 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20197513 (View on PubMed)

Other Identifiers

04-800

Identifier Type: -

Identifier Source: org_study_id