Cardio-OncologyNCT06309862
Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy
An observational study of Cardio-Oncology and Cardiomyopathy Due to Drug, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardio-Oncology, Cardiomyopathy Due to Drug
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This pilot study will include 15 patients recruited from Odette Cancer Centre at Sunnybrook Health Sciences Center who have skin cancer and are eligible for immunotherapy treatment.
Who may be able to join
- All patients 18 years of age, or older, with skin cancer and eligible for ICI treatment with a combination of a) nivolumab, b) pembrolizumab, or c) ipilimumab.
- Able to provide informed consent
- Able to travel to SHSC for cardiac imaging.
Who cannot join
- Life expectancy equal to, or less than, 12 months
- Participating in another clinical trial
- Treated with ICI in the past
- History of cardiac disease (e.g. heart failure, myocardial infarction, atrial fibrillation, unstable angina)
- Pregnant patients
- Impaired renal function (GFR equal to, or less than, 30mL/min)
- Contraindications for MRI (e.g. pacemaker).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
Thayalasuthan Vivekanandan, MD, (416) 480-6100 ext. 89291, thayalasuthan.vivekanandan@Sunnybrook.ca
Navpreet Sekhon, MB Bch BAO, (416) 480-6100 ext. 85466, navpreet.sekhon@sri.utoronto.ca
About this study
Official title: Association of Immune Checkpoint Inhibitor Therapy for Cancer With Early Myocardial Tissue and Biomarker Changes During Treatment - Implication for Risk of Myocarditis and Cardiomyopathy
Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes.
Read the detailed description
As patients going through cancer therapy live longer, they are at a higher risk of developing cardiovascular disease. Hence the evolving field of Cardio-Oncology has garnered much attention and importance. In recent years, immune checkpoint inhibitors (ICI) have become an essential component of cancer therapy, significantly improving patient outcomes that were previously considered palliative, e.g. metastatic melanoma, renal cell or lung cancer, and these therapies have improved survival.
With ICI therapy and especially with combination therapy, patients may develop severe ICI-related adverse events, e.g. myocarditis (1-5%) which is fatal in 30-50% of the patients. Another more significant subgroup of patients will develop non-inflammatory cardiomyopathy or other major cardiac events like cardiovascular death, cardiac arrest etc. There is also evidence that during ICI treatment atherosclerotic disease may progress. Identifying patients at risk for both remains a major challenge and is a knowledge gap in Cardio-Oncology.
Cardiovascular magnetic resonance (CMR) is a unique, highly reproducible, multiparametric method for non-invasive myocardial tissue characterization for diagnosing myocardial inflammation. Biomarkers like quantitative cardiac relaxometry (T1/T2-Mapping) with extracellular volume fraction (ECV), delayed gadolinium enhancement (LGE) or myocardial strain show insights into myocardial tissue composition. These biomarkers have the potential to identify early myocardial changes before the risk of clinical myocarditis or non-inflammatory cardiomyopathy occurs and may therefore help identify early myocardial tissue changes during ICI treatment and help identify patients at risk early on. Also, CMR can assess the aorta with high temporal and spatial resolution to identify atherosclerotic changes.
Only a few retrospective studies and case reports with small numbers of patients have investigated ICI-related cardiac events during treatment. Evidence shows that many patients present with heart failure (~80%), but troponin is only elevated in ~45%. This indicates that ICI-associated left ventricular (LV) dysfunction may exist without troponin elevation. Other data suggests that the ICI-associated myocardial tissue inflammation pattern might differ from viral myocarditis. The myocardial T1/T2 relaxation times may be elevated during ICI-associated myocardial inflammation. There is also evidence that strain changes are associated with adverse events within 30 days of treatment. However, all these studies demonstrate CMR findings when patients have already developed LV dysfunction or myocarditis. The proposed project would be the first prospective study to get deeper insights into serial, systematic ICI-associated myocardial tissue changes during treatment and their correlation with serum biomarkers and clinical symptoms.
- Conditions
- Cardio-Oncology, Cardiomyopathy Due to Drug
- Keywords
- Cardio-Oncology, Immunotherapy, Cardiomyopathy, Cardiac MRI, Myocardial tissue changes
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with skin cancer eligible for dual ICI treatment. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Define changes in CMR tissue and blood biomarkers during ICI treatment.
The following parameters are investigated to assess for underlying myocardial remodelling and/or inflammation during treatment with ICI.
Left ventricular volumes in ml Left ventricular ejection fraction in percentage T1 Mapping: T1 relaxation time in milliseconds T2 Mapping: T2 relaxation time in milliseconds ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)) in percentage Strain (GCS, GLS, GRS) reported as a percentage, formula =(Max Length-Initial Length)/Initial Length LGE is qualitatively described as categorical variables e.g. epicardial, mid-myocardial, subendocardial or transmural.
LGE is quantified as mass in gram and as percentage of the LV mass. High sensitivity troponin 1 nanogram/ mL B-type natriuretic peptide (BNP) nanogram/L High sensitivity CRP in mg/L
Measured: Baseline, 6 weeks and 6 months
Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction.
This analysis is to determine if the biomarkers are associated with LVEF changes over time.
Left ventricular volumes in ml Left ventricular ejection fraction in percentage T1 Mapping: T1 relaxation time in milliseconds T2 Mapping: T2 relaxation time in milliseconds ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)) in percentage Strain (GCS, GLS, GRS) reported as a percentage, formula =(Max Length-Initial Length)/Initial Length LGE is qualitatively described as categorical variables e.g. epicardial, mid-myocardial, subendocardial or transmural.
LGE is quantified as mass in gram and as percentage of the LV mass.
Measured: Baseline, 6 weeks and 6 months
Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction.
This analysis is to determine if blood biomarkers are associated with LVEF changes over time.
High sensitivity troponin 1 nanogram/ mL B-type natriuretic peptide (BNP) nanogram/L High sensitivity CRP in mg/L
Measured: Baseline, 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cardio-OncologyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Houbois, Sunnybrook Health Sciences Centre
- Investigators
- Christian Houbois, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309862
- Sponsor's protocol ID
- 5993
- Status last verified
- Jun 2024
- First submitted
- 12 Feb 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data with other researchers.
Publications
Thavendiranathan P, Abdel-Qadir H, Fischer HD, Camacho X, Amir E, Austin PC, Lee DS. Breast Cancer Therapy-Related Cardiac Dysfunction in Adult Women Treated in Routine Clinical Practice: A Population-Based Cohort Study. J Clin Oncol. 2016 Jul 1;34(19):2239-46. doi: 10.1200/JCO.2015.65.1505. Epub 2016 Apr 18.
PubMed 27091709Postow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015 Jun 10;33(17):1974-82. doi: 10.1200/JCO.2014.59.4358. Epub 2015 Jan 20.
PubMed 25605845Postow MA, Chesney J, Pavlick AC, Robert C, Grossmann K, McDermott D, Linette GP, Meyer N, Giguere JK, Agarwala SS, Shaheen M, Ernstoff MS, Minor D, Salama AK, Taylor M, Ott PA, Rollin LM, Horak C, Gagnier P, Wolchok JD, Hodi FS. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015 May 21;372(21):2006-17. doi: 10.1056/NEJMoa1414428. Epub 2015 Apr 20.
PubMed 25891304Wang DY, Salem JE, Cohen JV, Chandra S, Menzer C, Ye F, Zhao S, Das S, Beckermann KE, Ha L, Rathmell WK, Ancell KK, Balko JM, Bowman C, Davis EJ, Chism DD, Horn L, Long GV, Carlino MS, Lebrun-Vignes B, Eroglu Z, Hassel JC, Menzies AM, Sosman JA, Sullivan RJ, Moslehi JJ, Johnson DB. Fatal Toxic Effects Associated With Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis. JAMA Oncol. 2018 Dec 1;4(12):1721-1728. doi: 10.1001/jamaoncol.2018.3923.
PubMed 30242316Lyon AR, Yousaf N, Battisti NML, Moslehi J, Larkin J. Immune checkpoint inhibitors and cardiovascular toxicity. Lancet Oncol. 2018 Sep;19(9):e447-e458. doi: 10.1016/S1470-2045(18)30457-1.
PubMed 30191849Escudier M, Cautela J, Malissen N, Ancedy Y, Orabona M, Pinto J, Monestier S, Grob JJ, Scemama U, Jacquier A, Lalevee N, Barraud J, Peyrol M, Laine M, Bonello L, Paganelli F, Cohen A, Barlesi F, Ederhy S, Thuny F. Clinical Features, Management, and Outcomes of Immune Checkpoint Inhibitor-Related Cardiotoxicity. Circulation. 2017 Nov 21;136(21):2085-2087. doi: 10.1161/CIRCULATIONAHA.117.030571. No abstract available.
PubMed 29158217Zhang L, Awadalla M, Mahmood SS, Nohria A, Hassan MZO, Thuny F, Zlotoff DA, Murphy SP, Stone JR, Golden DLA, Alvi RM, Rokicki A, Jones-O'Connor M, Cohen JV, Heinzerling LM, Mulligan C, Armanious M, Barac A, Forrestal BJ, Sullivan RJ, Kwong RY, Yang EH, Damrongwatanasuk R, Chen CL, Gupta D, Kirchberger MC, Moslehi JJ, Coelho-Filho OR, Ganatra S, Rizvi MA, Sahni G, Tocchetti CG, Mercurio V, Mahmoudi M, Lawrence DP, Reynolds KL, Weinsaft JW, Baksi AJ, Ederhy S, Groarke JD, Lyon AR, Fradley MG, Thavendiranathan P, Neilan TG. Cardiovascular magnetic resonance in immune checkpoint inhibitor-associated myocarditis. Eur Heart J. 2020 May 7;41(18):1733-1743. doi: 10.1093/eurheartj/ehaa051.
PubMed 32112560Drobni ZD, Gongora C, Taron J, Suero-Abreu GA, Karady J, Gilman HK, Supraja S, Nikolaidou S, Leeper N, Merkely B, Maurovich-Horvat P, Foldyna B, Neilan TG. Impact of immune checkpoint inhibitors on atherosclerosis progression in patients with lung cancer. J Immunother Cancer. 2023 Jul;11(7):e007307. doi: 10.1136/jitc-2023-007307.
PubMed 37433718Bellenger NG, Burgess MI, Ray SG, Lahiri A, Coats AJ, Cleland JG, Pennell DJ. Comparison of left ventricular ejection fraction and volumes in heart failure by echocardiography, radionuclide ventriculography and cardiovascular magnetic resonance; are they interchangeable? Eur Heart J. 2000 Aug;21(16):1387-96. doi: 10.1053/euhj.2000.2011.
PubMed 10952828Grothues F, Smith GC, Moon JC, Bellenger NG, Collins P, Klein HU, Pennell DJ. Comparison of interstudy reproducibility of cardiovascular magnetic resonance with two-dimensional echocardiography in normal subjects and in patients with heart failure or left ventricular hypertrophy. Am J Cardiol. 2002 Jul 1;90(1):29-34. doi: 10.1016/s0002-9149(02)02381-0.
PubMed 12088775Quinaglia T, Gongora C, Awadalla M, Hassan MZO, Zafar A, Drobni ZD, Mahmood SS, Zhang L, Coelho-Filho OR, Suero-Abreu GA, Rizvi MA, Sahni G, Mandawat A, Zatarain-Nicolas E, Mahmoudi M, Sullivan R, Ganatra S, Heinzerling LM, Thuny F, Ederhy S, Gilman HK, Sama S, Nikolaidou S, Mansilla AG, Calles A, Cabral M, Fernandez-Aviles F, Gavira JJ, Gonzalez NS, Garcia de Yebenes Castro M, Barac A, Afilalo J, Zlotoff DA, Zubiri L, Reynolds KL, Devereux R, Hung J, Picard MH, Yang EH, Gupta D, Michel C, Lyon AR, Chen CL, Nohria A, Fradley MG, Thavendiranathan P, Neilan TG. Global Circumferential and Radial Strain Among Patients With Immune Checkpoint Inhibitor Myocarditis. JACC Cardiovasc Imaging. 2022 Nov;15(11):1883-1896. doi: 10.1016/j.jcmg.2022.06.014. Epub 2022 Sep 14.
PubMed 36357131Mordi I, Carrick D, Bezerra H, Tzemos N. T1 and T2 mapping for early diagnosis of dilated non-ischaemic cardiomyopathy in middle-aged patients and differentiation from normal physiological adaptation. Eur Heart J Cardiovasc Imaging. 2016 Jul;17(7):797-803. doi: 10.1093/ehjci/jev216. Epub 2015 Sep 10.
PubMed 26358692Thavendiranathan P, Walls M, Giri S, Verhaert D, Rajagopalan S, Moore S, Simonetti OP, Raman SV. Improved detection of myocardial involvement in acute inflammatory cardiomyopathies using T2 mapping. Circ Cardiovasc Imaging. 2012 Jan;5(1):102-10. doi: 10.1161/CIRCIMAGING.111.967836. Epub 2011 Oct 28.
PubMed 22038988Messroghli DR, Moon JC, Ferreira VM, Grosse-Wortmann L, He T, Kellman P, Mascherbauer J, Nezafat R, Salerno M, Schelbert EB, Taylor AJ, Thompson R, Ugander M, van Heeswijk RB, Friedrich MG. Clinical recommendations for cardiovascular magnetic resonance mapping of T1, T2, T2* and extracellular volume: A consensus statement by the Society for Cardiovascular Magnetic Resonance (SCMR) endorsed by the European Association for Cardiovascular Imaging (EACVI). J Cardiovasc Magn Reson. 2017 Oct 9;19(1):75. doi: 10.1186/s12968-017-0389-8.
PubMed 28992817Hor KN, Gottliebson WM, Carson C, Wash E, Cnota J, Fleck R, Wansapura J, Klimeczek P, Al-Khalidi HR, Chung ES, Benson DW, Mazur W. Comparison of magnetic resonance feature tracking for strain calculation with harmonic phase imaging analysis. JACC Cardiovasc Imaging. 2010 Feb;3(2):144-51. doi: 10.1016/j.jcmg.2009.11.006.
PubMed 20159640
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Immune Checkpoint Inhibitor Therapy for Cancer With Early Myocardial Tissue and Biomarker Changes During Treatment - Implication for Risk of Myocarditis and Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06309862
- Acronym / sponsor ID
- 5993
- Conditions
- Cardio-Oncology, Cardiomyopathy Due to Drug
- Keywords
- Cardio-Oncology, Immunotherapy, Cardiomyopathy, Cardiac MRI, Myocardial tissue changes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing dual treatment with Immune checkpoint inhibitors (ICI) for various cancers, e.g. melanoma, are at increased risk of developing myocarditis and cardiomyopathy. Currently, only limited data on serial myocardial tissue changes during treatment and whether they predict outcomes are available. Cardiac MRI (CMR) is the reference standard for non-invasive myocardial volumes/function analysis and uniquely characterizes myocardial tissue. Therefore, it may help detect myocardial tissue changes during treatment and help early treatment and prevent adverse cardiac outcomes.
Detailed description
As patients going through cancer therapy live longer, they are at a higher risk of developing cardiovascular disease. Hence the evolving field of Cardio-Oncology has garnered much attention and importance. In recent years, immune checkpoint inhibitors (ICI) have become an essential component of cancer therapy, significantly improving patient outcomes that were previously considered palliative, e.g. metastatic melanoma, renal cell or lung cancer, and these therapies have improved survival.
With ICI therapy and especially with combination therapy, patients may develop severe ICI-related adverse events, e.g. myocarditis (1-5%) which is fatal in 30-50% of the patients. Another more significant subgroup of patients will develop non-inflammatory cardiomyopathy or other major cardiac events like cardiovascular death, cardiac arrest etc. There is also evidence that during ICI treatment atherosclerotic disease may progress. Identifying patients at risk for both remains a major challenge and is a knowledge gap in Cardio-Oncology.
Cardiovascular magnetic resonance (CMR) is a unique, highly reproducible, multiparametric method for non-invasive myocardial tissue characterization for diagnosing myocardial inflammation. Biomarkers like quantitative cardiac relaxometry (T1/T2-Mapping) with extracellular volume fraction (ECV), delayed gadolinium enhancement (LGE) or myocardial strain show insights into myocardial tissue composition. These biomarkers have the potential to identify early myocardial changes before the risk of clinical myocarditis or non-inflammatory cardiomyopathy occurs and may therefore help identify early myocardial tissue changes during ICI treatment and help identify patients at risk early on. Also, CMR can assess the aorta with high temporal and spatial resolution to identify atherosclerotic changes.
Only a few retrospective studies and case reports with small numbers of patients have investigated ICI-related cardiac events during treatment. Evidence shows that many patients present with heart failure (~80%), but troponin is only elevated in ~45%. This indicates that ICI-associated left ventricular (LV) dysfunction may exist without troponin elevation. Other data suggests that the ICI-associated myocardial tissue inflammation pattern might differ from viral myocarditis. The myocardial T1/T2 relaxation times may be elevated during ICI-associated myocardial inflammation. There is also evidence that strain changes are associated with adverse events within 30 days of treatment. However, all these studies demonstrate CMR findings when patients have already developed LV dysfunction or myocarditis. The proposed project would be the first prospective study to get deeper insights into serial, systematic ICI-associated myocardial tissue changes during treatment and their correlation with serum biomarkers and clinical symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with skin cancer eligible for dual ICI treatment. | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This pilot study will include 15 patients recruited from Odette Cancer Centre at Sunnybrook Health Sciences Center who have skin cancer and are eligible for immunotherapy treatment.
Key inclusion criteria (3 listed)
- All patients 18 years of age, or older, with skin cancer and eligible for ICI treatment with a combination of a) nivolumab, b) pembrolizumab, or c) ipilimumab.
- Able to provide informed consent
- Able to travel to SHSC for cardiac imaging.
Key exclusion criteria (7 listed)
- Life expectancy equal to, or less than, 12 months
- Participating in another clinical trial
- Treated with ICI in the past
- History of cardiac disease (e.g. heart failure, myocardial infarction, atrial fibrillation, unstable angina)
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Define changes in CMR tissue and blood biomarkers during ICI treatment.
Time frame: Baseline, 6 weeks and 6 months
The following parameters are investigated to assess for underlying myocardial remodelling and/or inflammation during treatment with ICI. Left ventricular volumes in ml Left ventricular ejection fraction in percentage T1 Mapping: T1 relaxation time in milliseconds T2 Mapping: T2 relaxation time in milliseconds ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)) in percentage Strain (GCS, GLS, GRS) reported as a percentage, formula =(Max Length-Initial Length)/Initial Length LGE is qualitatively described as categorical variables e.g. epicardial, mid-myocardial, subendocardial or transmural. LGE is quantified as mass in gram and as percentage of the LV mass. High sensitivity troponin 1 nanogram/ mL B-type natriuretic peptide (BNP) nanogram/L High sensitivity CRP in mg/L
Investigate associations between CMR imaging biomarkers and CMR-defined left ventricular ejection fraction.
Time frame: Baseline, 6 weeks and 6 months
This analysis is to determine if the biomarkers are associated with LVEF changes over time. Left ventricular volumes in ml Left ventricular ejection fraction in percentage T1 Mapping: T1 relaxation time in milliseconds T2 Mapping: T2 relaxation time in milliseconds ECV = (1-hematocrit) × (Δ(1/T1myocardium)/Δ(1/T1blood)) in percentage Strain (GCS, GLS, GRS) reported as a percentage, formula =(Max Length-Initial Length)/Initial Length LGE is qualitatively described as categorical variables e.g. epicardial, mid-myocardial, subendocardial or transmural. LGE is quantified as mass in gram and as percentage of the LV mass.
Investigate associations between serum biomarkers and CMR-defined left ventricular ejection fraction.
Time frame: Baseline, 6 weeks and 6 months
This analysis is to determine if blood biomarkers are associated with LVEF changes over time. High sensitivity troponin 1 nanogram/ mL B-type natriuretic peptide (BNP) nanogram/L High sensitivity CRP in mg/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Background: PubMed 27091709Thavendiranathan P, Abdel-Qadir H, Fischer HD, Camacho X, Amir E, Austin PC, Lee DS. Breast Cancer Therapy-Related Cardiac Dysfunction in Adult Women Treated in Routine Clinical Practice: A Population-Based Cohort Study. J Clin Oncol. 2016 Jul 1;34(19):2239-46. doi: 10.1200/JCO.2015.65.1505. Epub 2016 Apr 18.
- Background: PubMed 25605845Postow MA, Callahan MK, Wolchok JD. Immune Checkpoint Blockade in Cancer Therapy. J Clin Oncol. 2015 Jun 10;33(17):1974-82. doi: 10.1200/JCO.2014.59.4358. Epub 2015 Jan 20.
- Background: PubMed 25891304Postow MA, Chesney J, Pavlick AC, Robert C, Grossmann K, McDermott D, Linette GP, Meyer N, Giguere JK, Agarwala SS, Shaheen M, Ernstoff MS, Minor D, Salama AK, Taylor M, Ott PA, Rollin LM, Horak C, Gagnier P, Wolchok JD, Hodi FS. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015 May 21;372(21):2006-17. doi: 10.1056/NEJMoa1414428. Epub 2015 Apr 20.
- Background: PubMed 30242316Wang DY, Salem JE, Cohen JV, Chandra S, Menzer C, Ye F, Zhao S, Das S, Beckermann KE, Ha L, Rathmell WK, Ancell KK, Balko JM, Bowman C, Davis EJ, Chism DD, Horn L, Long GV, Carlino MS, Lebrun-Vignes B, Eroglu Z, Hassel JC, Menzies AM, Sosman JA, Sullivan RJ, Moslehi JJ, Johnson DB. Fatal Toxic Effects Associated With Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis. JAMA Oncol. 2018 Dec 1;4(12):1721-1728. doi: 10.1001/jamaoncol.2018.3923.
- Background: PubMed 30191849Lyon AR, Yousaf N, Battisti NML, Moslehi J, Larkin J. Immune checkpoint inhibitors and cardiovascular toxicity. Lancet Oncol. 2018 Sep;19(9):e447-e458. doi: 10.1016/S1470-2045(18)30457-1.
- Background: PubMed 29158217Escudier M, Cautela J, Malissen N, Ancedy Y, Orabona M, Pinto J, Monestier S, Grob JJ, Scemama U, Jacquier A, Lalevee N, Barraud J, Peyrol M, Laine M, Bonello L, Paganelli F, Cohen A, Barlesi F, Ederhy S, Thuny F. Clinical Features, Management, and Outcomes of Immune Checkpoint Inhibitor-Related Cardiotoxicity. Circulation. 2017 Nov 21;136(21):2085-2087. doi: 10.1161/CIRCULATIONAHA.117.030571. No abstract available.
- Background: PubMed 32112560Zhang L, Awadalla M, Mahmood SS, Nohria A, Hassan MZO, Thuny F, Zlotoff DA, Murphy SP, Stone JR, Golden DLA, Alvi RM, Rokicki A, Jones-O'Connor M, Cohen JV, Heinzerling LM, Mulligan C, Armanious M, Barac A, Forrestal BJ, Sullivan RJ, Kwong RY, Yang EH, Damrongwatanasuk R, Chen CL, Gupta D, Kirchberger MC, Moslehi JJ, Coelho-Filho OR, Ganatra S, Rizvi MA, Sahni G, Tocchetti CG, Mercurio V, Mahmoudi M, Lawrence DP, Reynolds KL, Weinsaft JW, Baksi AJ, Ederhy S, Groarke JD, Lyon AR, Fradley MG, Thavendiranathan P, Neilan TG. Cardiovascular magnetic resonance in immune checkpoint inhibitor-associated myocarditis. Eur Heart J. 2020 May 7;41(18):1733-1743. doi: 10.1093/eurheartj/ehaa051.
- Background: PubMed 37433718Drobni ZD, Gongora C, Taron J, Suero-Abreu GA, Karady J, Gilman HK, Supraja S, Nikolaidou S, Leeper N, Merkely B, Maurovich-Horvat P, Foldyna B, Neilan TG. Impact of immune checkpoint inhibitors on atherosclerosis progression in patients with lung cancer. J Immunother Cancer. 2023 Jul;11(7):e007307. doi: 10.1136/jitc-2023-007307.
- Background: PubMed 10952828Bellenger NG, Burgess MI, Ray SG, Lahiri A, Coats AJ, Cleland JG, Pennell DJ. Comparison of left ventricular ejection fraction and volumes in heart failure by echocardiography, radionuclide ventriculography and cardiovascular magnetic resonance; are they interchangeable? Eur Heart J. 2000 Aug;21(16):1387-96. doi: 10.1053/euhj.2000.2011.
- Background: PubMed 12088775Grothues F, Smith GC, Moon JC, Bellenger NG, Collins P, Klein HU, Pennell DJ. Comparison of interstudy reproducibility of cardiovascular magnetic resonance with two-dimensional echocardiography in normal subjects and in patients with heart failure or left ventricular hypertrophy. Am J Cardiol. 2002 Jul 1;90(1):29-34. doi: 10.1016/s0002-9149(02)02381-0.
- Background: PubMed 36357131Quinaglia T, Gongora C, Awadalla M, Hassan MZO, Zafar A, Drobni ZD, Mahmood SS, Zhang L, Coelho-Filho OR, Suero-Abreu GA, Rizvi MA, Sahni G, Mandawat A, Zatarain-Nicolas E, Mahmoudi M, Sullivan R, Ganatra S, Heinzerling LM, Thuny F, Ederhy S, Gilman HK, Sama S, Nikolaidou S, Mansilla AG, Calles A, Cabral M, Fernandez-Aviles F, Gavira JJ, Gonzalez NS, Garcia de Yebenes Castro M, Barac A, Afilalo J, Zlotoff DA, Zubiri L, Reynolds KL, Devereux R, Hung J, Picard MH, Yang EH, Gupta D, Michel C, Lyon AR, Chen CL, Nohria A, Fradley MG, Thavendiranathan P, Neilan TG. Global Circumferential and Radial Strain Among Patients With Immune Checkpoint Inhibitor Myocarditis. JACC Cardiovasc Imaging. 2022 Nov;15(11):1883-1896. doi: 10.1016/j.jcmg.2022.06.014. Epub 2022 Sep 14.
- Background: PubMed 26358692Mordi I, Carrick D, Bezerra H, Tzemos N. T1 and T2 mapping for early diagnosis of dilated non-ischaemic cardiomyopathy in middle-aged patients and differentiation from normal physiological adaptation. Eur Heart J Cardiovasc Imaging. 2016 Jul;17(7):797-803. doi: 10.1093/ehjci/jev216. Epub 2015 Sep 10.
- Individual participant dataSharing planned: No. No plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Houbois, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardio-Oncology and Cardiomyopathy Due to Drug, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Houbois, MD ((416) 480-6100, christian.houbois@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define changes in CMR tissue and blood biomarkers during ICI treatment. (time frame: Baseline, 6 weeks and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309862, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.