The CAROLE (CArdiac Related Oncologic Late Effects) Study

NCT03235427 | Completed

• 1 other identifier: IIS-0046
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery disease. The purpose of CAROLE is to check the heart health of women who received breast cancer treatments in the past and protect them from future heart disease.

Conditions

Coronary Artery Disease; Cardiac Disease; Cardiac Toxicity; Radiation; Radiation Therapy; Atherosclerotic Heart Disease; Cardiotoxicity; Breast Cancer; Lung Cancer; Lymphoma; Cancer; Carcinoma, Intraductal, Noninfiltrating

Keywords

Coronary; Coronary Disease; Coronary Arteriosclerosis; Heart Disease; Cardiotoxicity; Breast Cancer; Carcinoma; Coronary Vessels; Radiation; Radiation Therapy; Coronary Artery Disease; CAD; RT; CT; Cardiac toxicity; Cardiac calcium score; Chest RT; Lung Cancer; Lymphoma; Cardiac CT Scan; Coronary Artery; Coronary arteries; Cardiac Side Effect; Cardiac tissue; Cardiac

Outcome Measures

Primary Outcomes (3)

• Multimodality Cardiology Assessment- EKG

  Assess whether radiation to the heart is associated with increased pre-clinical and clinical cardiac disease (as determined by a composite of multimodality cardiology assessments including EKG. Studies will be read using a standard, evidence based, set of criterion and documented using study templates) and compared to patients who did not receive radiation to the heart. All cardiac tests will be reviewed and reported as a composite with one the following; No evidence of disease/unrelated, preclinical disease, or clinical disease (non-numerically) based on the Cardiologists read of the study based on standard Pre-Specified criteria.

  1 Year

• Multimodality Cardiology Assessment- Echocardiogram with Strain

  Assess whether radiation to the heart is associated with increased pre-clinical and clinical cardiac disease (as determined by a composite of multimodality cardiology assessments including Echocardiogram with Strain. All cardiac tests will be reviewed and reported as a composite with one the following; No evidence of disease/unrelated, preclinical disease, or clinical disease (non-numerically) based on the Cardiologists read of the study based on standard Pre-Specified criteria.

  1 Year

• Multimodality Cardiology Assessment- Coronary Artery Calcium (CAC) CT

  Assess whether radiation to the heart is associated with increased pre-clinical and clinical cardiac disease (as determined by a composite of multimodality cardiology assessments including Coronary Artery Calcium (CAC) CT. All cardiac tests will be reviewed and reported as a composite with one the following; No evidence of disease/unrelated, preclinical disease, or clinical disease (non-numerically) based on the Cardiologists read of the study based on standard Pre-Specified criteria.

  1 Year

Secondary Outcomes (1)

• Agatston Score

  1 Year

Other Outcomes (1)

• Composite Assessment of Cardiac Disease

  1 Year

Study Arms (2)

Received Radiation Therapy(RT)

Patients who had received radiotherapy will be sub-stratified into those who received treatment to the left or right breast.

Did not receive Radiation Therapy (RT)

Patients who did not receive radiation treatment, but received chemotherapy, hormonal therapy, and/or surgery will be used as study controls to compare the prevalence and burden of cardiac disease as compared to radiation patients.

Eligibility Criteria

• Age: 26 Years - 78 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 18-65 at the time of breast cancer diagnosis, with a minimum of 6 years since diagnosis, with no history of heart disease prior to participants breast cancer diagnosis.

You may qualify if:

• If you are a breast cancer survivor who was diagnosed between the ages of ≥ 18-65 years (now at age 26-78).
• It has been at least 6 years since you were diagnosed.
• If you did not have a diagnosis of heart disease before\* having breast cancer.
• (\*women diagnosed with heart disease after breast cancer may still be eligible)

You may not qualify if:

• Patients who are unable to care for themselves or who are unable to come in for testing due to health conditions or incarceration will be rescheduled or removed in the case of chronic ineligibility. No vulnerable patient populations will be used in this study. Patients will be excluded if they have any pre-existing cardiac disease at the time of diagnosis of their breast cancer (2004-2011).
• Pregnant and nursing women are ineligible.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health

Lake Success, New York, 11042, United States

Location

Related Publications (15)

• Andersen R, Wethal T, Gunther A, Fossa A, Edvardsen T, Fossa SD, Kjekshus J. Relation of coronary artery calcium score to premature coronary artery disease in survivors >15 years of Hodgkin's lymphoma. Am J Cardiol. 2010 Jan 15;105(2):149-52. doi: 10.1016/j.amjcard.2009.09.005. Epub 2009 Nov 14.

  PMID: 20102909 BACKGROUND

• Correa CR, Litt HI, Hwang WT, Ferrari VA, Solin LJ, Harris EE. Coronary artery findings after left-sided compared with right-sided radiation treatment for early-stage breast cancer. J Clin Oncol. 2007 Jul 20;25(21):3031-7. doi: 10.1200/JCO.2006.08.6595.

  PMID: 17634481 BACKGROUND

• Chang M, Suh J, Kirtani V, Dobrescu A, Haas J, Zeldis S, Shayani S, Hindenburg AA. Coronary Calcium Scanning in Patients after Adjuvant Radiation for Early Breast Cancer and Ductal Carcinoma In situ. Front Oncol. 2013 Sep 25;3:253. doi: 10.3389/fonc.2013.00253. eCollection 2013.

  PMID: 24093087 BACKGROUND

• Santoro F, Tarantino N, Pellegrino PL, Caivano M, Lopizzo A, Di Biase M, Brunetti ND. Cardiovascular sequelae of radiation therapy. Clin Res Cardiol. 2014 Dec;103(12):955-67. doi: 10.1007/s00392-014-0718-y. Epub 2014 May 7.

  PMID: 24803132 BACKGROUND

• Tjessem KH, Bosse G, Fossa K, Reinertsen KV, Fossa SD, Johansen S, Fossa A. Coronary calcium score in 12-year breast cancer survivors after adjuvant radiotherapy with low to moderate heart exposure - Relationship to cardiac radiation dose and cardiovascular risk factors. Radiother Oncol. 2015 Mar;114(3):328-34. doi: 10.1016/j.radonc.2015.01.006. Epub 2015 Jan 16.

  PMID: 25600105 BACKGROUND

• Ng AK. Review of the cardiac long-term effects of therapy for Hodgkin lymphoma. Br J Haematol. 2011 Jul;154(1):23-31. doi: 10.1111/j.1365-2141.2011.08713.x. Epub 2011 May 3.

  PMID: 21539537 BACKGROUND

• Feng M, Moran JM, Koelling T, Chughtai A, Chan JL, Freedman L, Hayman JA, Jagsi R, Jolly S, Larouere J, Soriano J, Marsh R, Pierce LJ. Development and validation of a heart atlas to study cardiac exposure to radiation following treatment for breast cancer. Int J Radiat Oncol Biol Phys. 2011 Jan 1;79(1):10-8. doi: 10.1016/j.ijrobp.2009.10.058. Epub 2010 Apr 24.

  PMID: 20421148 BACKGROUND

• Rademaker J, Schoder H, Ariaratnam NS, Strauss HW, Yahalom J, Steingart R, Oeffinger KC. Coronary artery disease after radiation therapy for Hodgkin's lymphoma: coronary CT angiography findings and calcium scores in nine asymptomatic patients. AJR Am J Roentgenol. 2008 Jul;191(1):32-7. doi: 10.2214/AJR.07.3112.

  PMID: 18562721 BACKGROUND

• Kim KP, Einstein AJ, Berrington de Gonzalez A. Coronary artery calcification screening: estimated radiation dose and cancer risk. Arch Intern Med. 2009 Jul 13;169(13):1188-94. doi: 10.1001/archinternmed.2009.162.

  PMID: 19597067 BACKGROUND

• DeSantis CE, Lin CC, Mariotto AB, Siegel RL, Stein KD, Kramer JL, Alteri R, Robbins AS, Jemal A. Cancer treatment and survivorship statistics, 2014. CA Cancer J Clin. 2014 Jul-Aug;64(4):252-71. doi: 10.3322/caac.21235. Epub 2014 Jun 1.

  PMID: 24890451 BACKGROUND

• Youlden DR, Cramb SM, Dunn NA, Muller JM, Pyke CM, Baade PD. The descriptive epidemiology of female breast cancer: an international comparison of screening, incidence, survival and mortality. Cancer Epidemiol. 2012 Jun;36(3):237-48. doi: 10.1016/j.canep.2012.02.007. Epub 2012 Mar 27.

  PMID: 22459198 BACKGROUND

• Gyenes G, Rutqvist LE, Liedberg A, Fornander T. Long-term cardiac morbidity and mortality in a randomized trial of pre- and postoperative radiation therapy versus surgery alone in primary breast cancer. Radiother Oncol. 1998 Aug;48(2):185-90. doi: 10.1016/s0167-8140(98)00062-0.

  PMID: 9783890 BACKGROUND

• Naghavi M, Falk E, Hecht HS, Jamieson MJ, Kaul S, Berman D, Fayad Z, Budoff MJ, Rumberger J, Naqvi TZ, Shaw LJ, Faergeman O, Cohn J, Bahr R, Koenig W, Demirovic J, Arking D, Herrera VL, Badimon J, Goldstein JA, Rudy Y, Airaksinen J, Schwartz RS, Riley WA, Mendes RA, Douglas P, Shah PK; SHAPE Task Force. From vulnerable plaque to vulnerable patient--Part III: Executive summary of the Screening for Heart Attack Prevention and Education (SHAPE) Task Force report. Am J Cardiol. 2006 Jul 17;98(2A):2H-15H. doi: 10.1016/j.amjcard.2006.03.002. Epub 2006 Jun 12.

  PMID: 16843744 BACKGROUND

• Darby SC, Ewertz M, McGale P, Bennet AM, Blom-Goldman U, Bronnum D, Correa C, Cutter D, Gagliardi G, Gigante B, Jensen MB, Nisbet A, Peto R, Rahimi K, Taylor C, Hall P. Risk of ischemic heart disease in women after radiotherapy for breast cancer. N Engl J Med. 2013 Mar 14;368(11):987-98. doi: 10.1056/NEJMoa1209825.

  PMID: 23484825 BACKGROUND

• Carr ZA, Land CE, Kleinerman RA, Weinstock RW, Stovall M, Griem ML, Mabuchi K. Coronary heart disease after radiotherapy for peptic ulcer disease. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):842-50. doi: 10.1016/j.ijrobp.2004.07.708.

  PMID: 15708264 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases; Cardiotoxicity; Breast Neoplasms; Lung Neoplasms; Lymphoma; Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Coronary Disease; Carcinoma

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Lucille Lee, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

• Lindsay L Puckett, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: August 1, 2017
• Study Start: June 27, 2017
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (1)