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Psychophysiology of Cardiovascular Reactivity

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of Miami
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

25 Years - 54 Years (Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    January 14, 2016
    Sponsor
    University of Miami
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005192
    Brief Title
    Psychophysiology of Cardiovascular Reactivity
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1986 (undefined)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Miami
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To determine why Black Americans have a higher prevalence of hypertension than whites by examining the interactions of psychosocial stressors and suppressed hostility with genetic or constitutional factors.
    Detailed Description
    BACKGROUND: Blacks in the United States have a much greater prevalence of essential hypertension than whites. The prevalence of hypertension for adults aged 18-74 has been estimated at 15.7 percent for white women, 18.5 percent for white men, 27.8 percent for Black men and 28.6 percent for Black women. Among adults who underwent screening for the Hypertension Detection and Follow-up Program, 36.2 percent of Black males and 38.2 percent of Black females either had diastolic blood pressures at least as high as 95 mmHg or were taking antihypertensive medications. The Black-white ratio for the prevalence of hypertension in this survey was approximately 2. Reportedly, the prevalence of hypertension among inner city Blacks may be as high as 50 percent. The exact causes of the disparity in hypertension prevalence between Blacks and whites are unknown, but genetic predisposition, psychosocial stress, and life-style factors such as high sodium ingestion and obesity have been implicated. None of these factors alone appears sufficient to account for the difference in the prevalence of hypertension between Blacks and whites, suggesting that multiple factors and/or interactions between factors may be involved. DESIGN NARRATIVE: The study is supported by a program project grant and thus includes many subprojects. Projects 1A through 1C were supported beginning in 1986. Project 1A examined the effects of cardiovascular and hormonal responses to standardized laboratory challenges as a function of race, sex, age, and normal blood pressure versus borderline hypertension. The subjects were classified according to four categories: Black or white race; male or female sex; normal or raised blood pressure; and ages 25-39 or 40-54, giving a total of 16 cells with 15 subjects in each. The subjects were given a physical examination, electrocardiogram, blood screening test as well as a battery of special tests including a Structured Interview for Type A behavior pattern, playing a video game, a test designed to elicit anger, and exercise on a bicycle ergometer. During these tasks subjects were monitored for heart rate and blood pressure, and blood was sampled for plasma catecholamines, renin, cortisol, aldosterone, and vasopressin. Various psychological tests were administered including the Cook-Medley hostility scale, the Life Orientation test, a job stress scale, the John Henryism Active Coping Scale and others. Urine samples were collected for electrolyte and catecholamine excretion and ambulatory blood pressure was monitored on a work day and on a non-work day. Project IB examined the effects of acute sodium loading and depletion on cardiovascular and hormonal reactivity as a function of race and sex. Normotensive subjects were classified according to two categories: Black or white race; male or female sex, with four cells of 15 subjects each. After the initial medical examination, subjects were seen three times at intervals of two weeks. Before each visit three overnight urine collections were made for electrolyte excretion evaluation. On these three visits subjects were randomized to either a control day, a sodium loading day, or sodium depletion day. On each of these days subjects were given three reactivity tests including the video game, exercise test, and speech-stressor task. The same psychological tests as in Project 1A were given on the mornings of the three testing days. Project 1C was a five-year follow-up of 80 subjects in the Study of Biobehavioral Factors Affecting Hypertension in Blacks. Subjects had a routine history and physical exam and were then given the Type A Interview, a video game, and an exercise task. Subjects also provided three overnight urine samples. Two substudies were also conducted. The goal of substudy 1 was to determine what psychosocial factors predicted cardiovascular responding at work in Black and white women. Black and white normotensive nurses between the ages of 20-45 years served as subjects. Substudy 2 examined the affective and physiological responses of Black and white college students during challenge. Normotensive Black and white men and women were monitored for blood pressure and heart rate during rest and during three tasks including mirror star tracing, hand immersion cold pressor, and speech stressor. The program project was renewed in 1996. Subproject 7 addresses the the problem of modifying risk in youth with high blood pressure. The subproject compares adolescents with high versus normal blood pressure in terms of fasting insulin, oral glucose tolerance, adiposity, aerobic fitness, diet, cardiac mass, autonomic reactivity, psychosocial characteristics and family medical history. Subproject 7 renewed as Subproject 1 in FY 2001 examines the long-term effects of three intervention conditions: a three month self-management intervention; a six month augmented self-management skill acquisition intervention program; and usual care. Subproject 8 renewed as Subproject 2 in FY 2001 involves behavioral intervention in post-myocardial infarction patients receiving standard pharmacological treatment or standard pharmacological treatment plus behavioral treatment including stress management, dietary supervision, and self-directed exercise.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypertension

    7. Study Design

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    54 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neil Schneiderman
    Organizational Affiliation
    University of Miami

    12. IPD Sharing Statement

    Citations:
    Citation
    Gellman MD, Ironson GH, Spitzer SB, Keenan M, Schneiderman N, Weidler DJ: Ambulatory Blood Pressure as a Function of Race, Gender, Place, and Mood. Circulation, 74(Suppl.)2, 319, 1986
    Results Reference
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    Citation
    Spitzer SB, Carver CS, Gerace TA, Tischenkel N, Gellman M, Schneiderman N: Locus of Control, John Henryism, Monitoring-Blunting, and Reactivity in the Miami Minority Hypertension Project. Society of Behavioral Medicine, 1986
    Results Reference
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    Citation
    Tischenkel N, Schneiderman N, Nelesen R, Vorp R, Gellman M, Gerace T, McCabe PM: Cardiovascular and Neurohumoral Baselines and Reactivity in the Miami Minority Hypertension Project. Society of Behavioral Medicine, 1986
    Results Reference
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    Citation
    Weintraub JK, Carver CS, McCabe PM, Spitzer S, Schneiderman J: Anger, Hostility, and Reactivity in the Miami Minority Hypertension Project. Society of Behavioral Medicine, 1986
    Results Reference
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    Citation
    Tishenkel N, Gellman M, Nelesen R, Schneiderman N: Behavioral Factors Affecting Blood Pressure in Blacks. Cardiovascular Disease Epidemiology Newsletter, 315, 1986
    Results Reference
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    Citation
    Larsen P, Schneiderman N, Pasin RD: Physiological Bases of Cardiovascular Psychophysiology. In: Coles M, Donchin E, Porges S (Eds), Psychophysiology: Systems, Processes and Applications. Guilford, 1986
    Results Reference
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    Citation
    Kaufman MP, Schneiderman N: Physiological Bases of Respiratory Psychophysiology. In: Coles M, Donchin E, Porges S (Eds), Psychophysiology: Systems, Processes and Applications. Guilford, 1986
    Results Reference
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    Citation
    Dimsdale J, Alpert B, Schneiderman N: Exercise as a Modulator of Cardiovascular Reactivity. In: Matthews K et al (Ed), Handbook of Stress, Reactivity, and Cardiovascular Disease. Wiley, 1986
    Results Reference
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    Citation
    Schneiderman N, Pickering T: Cardiovascular Measures of Physiologic Reactivity. In: Matthews K et al (Ed), Handbook of Stress, Reactivity, and Cardiovascular Disease. Wiley, 1986
    Results Reference
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    Citation
    Schneiderman N, Tischenkel N, Nelesen R: Anger, Aerobics, and Autonomic Reactivity. In: Schmidt T, Dembroski T, Blumchen C (Eds), Biological and Psychological Factors in Cardiovascular Disease. Springer, 1986
    Results Reference
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    PubMed Identifier
    3297408
    Citation
    Schneiderman N. Psychophysiologic factors in atherogenesis and coronary artery disease. Circulation. 1987 Jul;76(1 Pt 2):I41-7.
    Results Reference
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    Citation
    Ironson G, Gellman M, Spitzer S, Llabre M, Schneiderman N: Prediction of Ambulatory Blood Pressure as a Function of Laboratory Reactivity, Race, and Gender. Society of Behavioral Medicine, 1987
    Results Reference
    background
    PubMed Identifier
    2727222
    Citation
    Laperriere AR, VanDercar DH, Shyu LY, Ward MF, McCabe PM, Perry AC, Mosher PE, Schneiderman N. Microcomputer servo-controlled bicycle ergometer system for psychophysiological research. Psychophysiology. 1989 Mar;26(2):201-7. doi: 10.1111/j.1469-8986.1989.tb03157.x.
    Results Reference
    background
    PubMed Identifier
    3353490
    Citation
    Llabre MM, Ironson GH, Spitzer SB, Gellman MD, Weidler DJ, Schneiderman N. How many blood pressure measurements are enough? An application of generalizability theory to the study of blood pressure reliability. Psychophysiology. 1988 Jan;25(1):97-106. doi: 10.1111/j.1469-8986.1988.tb00967.x. No abstract available.
    Results Reference
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    Citation
    Schneiderman N, McCabe, PM: Psychophysiologic Strategies in Laboratory Research. In: Schneiderman N, Kaufmann P, Weiss SM (Eds), Handbook of Research Methods in Cardiovascular Behavioral Medicine. Plenum Press, New York, 1988
    Results Reference
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    PubMed Identifier
    3243218
    Citation
    Llabre MM, Ironson GH, Spitzer SB, Gellman MD, Weidler DJ, Schneiderman N. Blood pressure stability of normotensives and mild hypertensives in different settings. Health Psychol. 1988;7 Suppl:127-37. doi: 10.1037/h0090276.
    Results Reference
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    PubMed Identifier
    3241858
    Citation
    VanDercar DH, Laperriere AR, Shyu LY, Ward MF, McCabe PM, Perry A, Schneiderman N. Microcomputer automated system for measuring systolic time intervals in response to exercise and a psychophysiological task. Psychophysiology. 1988 Nov;25(6):703-11. doi: 10.1111/j.1469-8986.1988.tb01912.x. No abstract available.
    Results Reference
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    PubMed Identifier
    2727219
    Citation
    Ironson GH, Gellman MD, Spitzer SB, Llabre MM, De Carlo Pasin R, Weidler DJ, Schneiderman N. Predicting home and work blood pressure measurements from resting baselines and laboratory reactivity in black and white Americans. Psychophysiology. 1989 Mar;26(2):174-84. doi: 10.1111/j.1469-8986.1989.tb03151.x.
    Results Reference
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    PubMed Identifier
    2698349
    Citation
    Tischenkel NJ, Saab PG, Schneiderman N, Nelesen RA, Pasin RD, Goldstein DA, Spitzer SB, Woo-Ming R, Weidler DJ. Cardiovascular and neurohumoral responses to behavioral challenge as a function of race and sex. Health Psychol. 1989;8(5):503-24. doi: 10.1037//0278-6133.8.5.503.
    Results Reference
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    PubMed Identifier
    2630294
    Citation
    Durel LA, Carver CS, Spitzer SB, Llabre MM, Weintraub JK, Saab PG, Schneiderman N. Associations of blood pressure with self-report measures of anger and hostility among black and white men and women. Health Psychol. 1989;8(5):557-75. doi: 10.1037//0278-6133.8.5.557.
    Results Reference
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    PubMed Identifier
    1410171
    Citation
    Saab PG, Llabre MM, Hurwitz BE, Frame CA, Reineke LJ, Fins AI, McCalla J, Cieply LK, Schneiderman N. Myocardial and peripheral vascular responses to behavioral challenges and their stability in black and white Americans. Psychophysiology. 1992 Jul;29(4):384-97. doi: 10.1111/j.1469-8986.1992.tb01712.x.
    Results Reference
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    PubMed Identifier
    1639997
    Citation
    Schneiderman N. Ethnicity and ambulatory blood pressure measurement: relationship to clinic and laboratory measurements. J Clin Pharmacol. 1992 Jul;32(7):604-9. doi: 10.1002/j.1552-4604.1992.tb05768.x.
    Results Reference
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    PubMed Identifier
    1553403
    Citation
    Spitzer SB, Llabre MM, Ironson GH, Gellman MD, Schneiderman N. The influence of social situations on ambulatory blood pressure. Psychosom Med. 1992 Jan-Feb;54(1):79-86. doi: 10.1097/00006842-199201000-00010.
    Results Reference
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    PubMed Identifier
    1816598
    Citation
    Llabre MM, Spitzer SB, Saab PG, Ironson GH, Schneiderman N. The reliability and specificity of delta versus residualized change as measures of cardiovascular reactivity to behavioral challenges. Psychophysiology. 1991 Nov;28(6):701-11. doi: 10.1111/j.1469-8986.1991.tb01017.x.
    Results Reference
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    PubMed Identifier
    1758926
    Citation
    Peckerman A, Saab PG, McCabe PM, Skyler JS, Winters RW, Llabre MM, Schneiderman N. Blood pressure reactivity and perception of pain during the forehead cold pressor test. Psychophysiology. 1991 Sep;28(5):485-95. doi: 10.1111/j.1469-8986.1991.tb01985.x.
    Results Reference
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    PubMed Identifier
    2274617
    Citation
    Gellman M, Spitzer S, Ironson G, Llabre M, Saab P, DeCarlo Pasin R, Weidler DJ, Schneiderman N. Posture, place, and mood effects on ambulatory blood pressure. Psychophysiology. 1990 Sep;27(5):544-51. doi: 10.1111/j.1469-8986.1990.tb01972.x.
    Results Reference
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    PubMed Identifier
    2239897
    Citation
    Donahue RP, Skyler JS, Schneiderman N, Prineas RJ. Hyperinsulinemia and elevated blood pressure: cause, confounder, or coincidence? Am J Epidemiol. 1990 Nov;132(5):827-36. doi: 10.1093/oxfordjournals.aje.a115725. No abstract available.
    Results Reference
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    PubMed Identifier
    8008792
    Citation
    Peckerman A, Hurwitz BE, Saab PG, Llabre MM, McCabe PM, Schneiderman N. Stimulus dimensions of the cold pressor test and the associated patterns of cardiovascular response. Psychophysiology. 1994 May;31(3):282-90. doi: 10.1111/j.1469-8986.1994.tb02217.x.
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    PubMed Identifier
    8218626
    Citation
    Hurwitz BE, Nelesen RA, Saab PG, Nagel JH, Spitzer SB, Gellman MD, McCabe PM, Phillips DJ, Schneiderman N. Differential patterns of dynamic cardiovascular regulation as a function of task. Biol Psychol. 1993 Aug;36(1-2):75-95. doi: 10.1016/0301-0511(93)90082-j.
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    PubMed Identifier
    8218621
    Citation
    Hurwitz BE, Shyu LY, Lu CC, Reddy SP, Schneiderman N, Nagel JH. Signal fidelity requirements for deriving impedance cardiographic measures of cardiac function over a broad heart rate range. Biol Psychol. 1993 Aug;36(1-2):3-21. doi: 10.1016/0301-0511(93)90076-k.
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    8416061
    Citation
    Durel LA, Kus LA, Anderson NB, McNeilly M, Llabre MM, Spitzer S, Saab PG, Efland J, Williams R, Schneiderman N. Patterns and stability of cardiovascular responses to variations of the cold pressor test. Psychophysiology. 1993 Jan;30(1):39-46. doi: 10.1111/j.1469-8986.1993.tb03203.x.
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    8340242
    Citation
    Llabre MM, Saab PG, Hurwitz BE, Schneiderman N, Frame CA, Spitzer S, Phillips D. The stability of cardiovascular parameters under different behavioral challenges: one-year follow-up. Int J Psychophysiol. 1993 May;14(3):241-8. doi: 10.1016/0167-8760(93)90038-q.
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    8327622
    Citation
    Saab PG, Llabre MM, Hurwitz BE, Schneiderman N, Wohlgemuth W, Durel LA, Massie C, Nagel J. The cold pressor test: vascular and myocardial response patterns and their stability. Psychophysiology. 1993 Jul;30(4):366-73. doi: 10.1111/j.1469-8986.1993.tb02058.x.
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    Schriefers KH. [Mechanical ileus]. Chirurg. 1975 Feb;46(2):49-53. No abstract available. German.
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    9251164
    Citation
    Saab PG, Llabre MM, Schneiderman N, Hurwitz BE, McDonald PG, Evans J, Wohlgemuth W, Hayashi P, Klein B. Influence of ethnicity and gender on cardiovascular responses to active coping and inhibitory-passive coping challenges. Psychosom Med. 1997 Jul-Aug;59(4):434-46. doi: 10.1097/00006842-199707000-00014.
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    Citation
    Goldstein RZ, Hurwitz BE, Llabre MM, Schneiderman N, Gutt M, Skyler JS, Prineas RJ, Donahue RP. Modeling preclinical cardiovascular risk for use in epidemiologic studies: Miami community health study. Am J Epidemiol. 2001 Oct 15;154(8):765-76. doi: 10.1093/aje/154.8.765.
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    PubMed Identifier
    12462502
    Citation
    Kline KA, Saab PG, Llabre MM, Spitzer SB, Evans JD, McDonald PA, Schneiderman N. Hemodynamic response patterns: responder type differences in reactivity and recovery. Psychophysiology. 2002 Nov;39(6):739-46. doi: 10.1111/1469-8986.3960739.
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    12240671
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    Llabre MM, Spitzer SB, Saab PG, Schneiderman N. Piecewise latent growth curve modeling of systolic blood pressure reactivity and recovery from the cold pressor test. Psychophysiology. 2001 Nov;38(6):951-60. doi: 10.1111/1469-8986.3860951.
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    12058006
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    Bearman KJ, La Greca AM. Assessing friend support of adolescents' diabetes care: the diabetes social support questionnaire-friends version. J Pediatr Psychol. 2002 Jul-Aug;27(5):417-28. doi: 10.1093/jpepsy/27.5.417.
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    PubMed Identifier
    11728009
    Citation
    Peckerman A, Hurwitz BE, Nagel JH, Leitten C, Agatston AS, Schneiderman N. Effects of gender and age on the cardiac baroreceptor reflex in hypertension. Clin Exp Hypertens. 2001 Nov;23(8):645-56. doi: 10.1081/ceh-100107394.
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    PubMed Identifier
    15470277
    Citation
    Hurwitz BE, Klimas NG, Llabre MM, Maher KJ, Skyler JS, Bilsker MS, McPherson-Baker S, Lawrence PJ, Laperriere AR, Greeson JM, Klaus JR, Lawrence R, Schneiderman N. HIV, metabolic syndrome X, inflammation, oxidative stress, and coronary heart disease risk : role of protease inhibitor exposure. Cardiovasc Toxicol. 2004;4(3):303-16. doi: 10.1385/ct:4:3:303.
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    Llabre MM, Spitzer S, Siegel S, Saab PG, Schneiderman N. Applying latent growth curve modeling to the investigation of individual differences in cardiovascular recovery from stress. Psychosom Med. 2004 Jan-Feb;66(1):29-41. doi: 10.1097/01.psy.0000107886.51781.9c.
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    Citation
    Williams RB, Barefoot JC, Schneiderman N. Psychosocial risk factors for cardiovascular disease: more than one culprit at work. JAMA. 2003 Oct 22;290(16):2190-2. doi: 10.1001/jama.290.16.2190. No abstract available.
    Results Reference
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