Heart AneurysmNCT06146751
A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus
An observational study of Heart Aneurysm, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The incidence of thrombosis in ventricular aneurysm was reported to be 35%-40%, which may lead to systemic thromboembolism. Patients with ventricular aneurysm without detectable thrombus are not routinely treated with anticoagulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Aneurysm
- What is being tested?
- Superparamagnetic Iron Oxide Nanoparticles
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2023to 31 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 patients with ventricular aneurysm and 10 to 20 patients after percutaneous ventricular reconstruction at the First Affiliated Hospital of Nanjing Medical University
Who may be able to join
- Age ≥ 18 years and ≤ 80 years;
- Patients with left ventricular aneurysm detected by transthoracic echocardiography or 180±30 days after percutaneous ventricular reconstruction;
- An informed consent form was signed voluntarily by the patients or an authorised family member.
Who cannot join
- Patients unable to lie down for any reason;
- Patients who are unable to undergo MRI for psychological (e.g. suffering from claustrophobia syndrome) or physical reasons (e.g. non-antimagnetic metal retention in the body, hearing impairment, involuntary body movements, etc.);
- Patients with a known history of iron allergy or hypersensitivity;
- Patients taking other oral or intravenous iron products;
- Patients with haemosiderin deposition or haemochromatosis;
- Pregnant or lactating women;
- Any other patient that the investigator deems inappropriate for enrolment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Chunjian Li, MD, PhD, +8613701465229, lijay@njmu.edu.cn
Zhenyu Lin, MD, +8618262712770, lzydoctor@126.com
About this study
Official title: A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus in Patients With Ventricular Aneurysm and After Percutaneous Ventricular Reconstruction
The incidence of thrombosis in ventricular aneurysm was reported to be 35%-40%, which may lead to systemic thromboembolism. Patients with ventricular aneurysm without detectable thrombus are not routinely treated with anticoagulation. Therefore, the accuracy of intracardiac thrombus detection has an important impact on clinical management decisions. Currently, transthoracic echocardiography is the most commonly used method to detect intracardiac thrombus, but its sensitivity and positive predictive value are low. Cardiac magnetic resonance has a higher diagnostic accuracy for intracardiac thrombus, and its sensitivity and positive predictive value are higher than those of transthoracic echocardiography and CT. However, the gadolinium-based contrast agents commonly used for enhanced magnetic resonance imaging have some problems such as nephrogenic systemic fibrosis, gadolinium deposition in the brain, and short imaging time. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, can be used for off-label enhanced magnetic resonance imaging. Its long intravascular half-life makes it suitable for enhanced magnetic resonance imaging with complex scanning procedures and long repetitive scans. Ferumoxytol is cleared from the blood pool by macrophages of the reticuloendothelial system, mainly in the spleen and lymph nodes. Therefore, ferumoxytol has a favourable safety even in adults and children with end-stage renal failure. The aim of this study is to evaluate the effectiveness of a novel ferumoxytol-enhanced cardiac magnetic resonance in detecting intracardiac thrombus in patients with ventricular aneurysm and after percutaneous ventricular reconstruction.
Read the detailed description
Ferumoxytol is a member of ultrasmall superparamagnetic iron oxide particles with an average diameter of 30 nm, originally developed as an intravascular contrast agent for MRI. Ferumoxytol was approved by the FDA in 2009 for the intravenous treatment of iron deficiency anaemia in adults with chronic kidney disease, and has also been used off-label as a non-gadolinium contrast agent for whole-body magnetic resonance imaging. Its iron oxide core is coated with dextran, which reduces immunogenicity and delays phagocytosis and the release of elemental iron from the core. As a result, ferumoxytol has a long intravascular half-life of approximately 15 hours and is slowly taken up by the macrophages of the reticuloendothelial system. Because of its long half-life, ferumoxytol is suitable for enhanced magnetic resonance imaging with complex scanning procedures and long repetitive scans. Ferumoxytol has been proved to be safe even in adults and children with end-stage renal failure. As feraheme is not available in the Chinese market, we experimentally synthesised a new formulation of ferumoxytol, which is identical to ferumoxytol in terms of physicochemical structure, pharmacokinetics and toxicological effects, at the request of Chia Tai Tianqing Pharmaceutical Group Co, Ltd (Nanjing, China) in 2014. This study is a single-centre, prospective, observational, non-randomised study. The study will enrol patients with ventricular aneurysm and after percutaneous ventricular reconstruction. The aim of this study is to evaluate the effectiveness of ferumoxytol-enhanced cardiac magnetic resonance imaging in detecting intracardiac thrombus in patients with ventricular aneurysm and left ventricular thrombus in the dynamic chamber and static chamber in patients 180±30 days after percutaneous ventricular reconstruction by comparing the detection rate of intracardiac thrombus with ferumoxytol-enhanced cardiac magnetic resonance imaging and transthoracic echocardiography, and to provide a clinical basis for the development and application of the new generation of magnetic resonance contrast agents in China. The echocardiography and magnetic resonance imaging experts were blinded to each other's results.
- Conditions
- Heart Aneurysm
- Being tested
- Superparamagnetic Iron Oxide Nanoparticles
- Keywords
- ferumoxytol, ultrasmall superparamagnetic iron oxide particles, contrast-enhanced magnetic resonance, thrombosis, ventricular aneurysm
- Medical subject headings
- Heart Aneurysm, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superparamagnetic Iron Oxide NanoparticlesDrug
Also called ferumoxytol
Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.
| Study group | Role | What they receive |
|---|---|---|
| patients with ventricular aneurysm and after percutaneous ventricular reconstruction | Patients with ventricular aneurysm and after percutaneous ventricular reconstruction undergo a novel ferumoxytol-enhanced cardiac magnetic resonance imaging and transthoracic echocardiography. Receives: Drug: Superparamagnetic Iron Oxide Nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection rate of intracardiac thrombus
Detection rate of intracardiac thrombus by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography
Measured: Nov. 1st, 2023 to Mar. 31st, 2025
detection rate of thrombus in dynamic chamber and static chamber
Detection rate of thrombus in dynamic chamber and static chamber by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography in patients after percutaneous ventricular reconstruction
Measured: Nov. 1st, 2023 to Mar. 31st, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start6 Nov 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Heart AneurysmStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Chunjian Li, MD, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146751
- Sponsor's protocol ID
- 024
- Status last verified
- Sep 2024
- First submitted
- 18 Nov 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delewi R, Zijlstra F, Piek JJ. Left ventricular thrombus formation after acute myocardial infarction. Heart. 2012 Dec;98(23):1743-9. doi: 10.1136/heartjnl-2012-301962. No abstract available.
PubMed 23151669El Ouazzani J, Jandou I. Aneurysm and pseudoaneurysm of the left ventricle. Ann Med Surg (Lond). 2022 Feb 24;75:103405. doi: 10.1016/j.amsu.2022.103405. eCollection 2022 Mar.
PubMed 35386778Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 Jan 29;127(4):e362-425. doi: 10.1161/CIR.0b013e3182742cf6. Epub 2012 Dec 17. No abstract available.
PubMed 23247304Whalen H, Dako F, Patel P, Sahbaz J, Hong-Zohlman S, White CS, Jeudy J. Role of Imaging for Suspected Cardiac Thrombus. Curr Treat Options Cardiovasc Med. 2019 Dec 9;21(12):81. doi: 10.1007/s11936-019-0792-6.
PubMed 31820132Allard L, Bernhard B, Windecker S, Valgimigli M, Grani C. Left ventricular thrombus in ischaemic heart disease: diagnosis, treatment, and gaps of knowledge. Eur Heart J Qual Care Clin Outcomes. 2022 Aug 17;8(5):496-509. doi: 10.1093/ehjqcco/qcab097.
PubMed 34928322Srichai MB, Junor C, Rodriguez LL, Stillman AE, Grimm RA, Lieber ML, Weaver JA, Smedira NG, White RD. Clinical, imaging, and pathological characteristics of left ventricular thrombus: a comparison of contrast-enhanced magnetic resonance imaging, transthoracic echocardiography, and transesophageal echocardiography with surgical or pathological validation. Am Heart J. 2006 Jul;152(1):75-84. doi: 10.1016/j.ahj.2005.08.021.
PubMed 16824834Wertman R, Altun E, Martin DR, Mitchell DG, Leyendecker JR, O'Malley RB, Parsons DJ, Fuller ER 3rd, Semelka RC. Risk of nephrogenic systemic fibrosis: evaluation of gadolinium chelate contrast agents at four American universities. Radiology. 2008 Sep;248(3):799-806. doi: 10.1148/radiol.2483072093. Epub 2008 Jul 15.
PubMed 18632533Sadowski EA, Bennett LK, Chan MR, Wentland AL, Garrett AL, Garrett RW, Djamali A. Nephrogenic systemic fibrosis: risk factors and incidence estimation. Radiology. 2007 Apr;243(1):148-57. doi: 10.1148/radiol.2431062144. Epub 2007 Jan 31.
PubMed 17267695Kribben A, Witzke O, Hillen U, Barkhausen J, Daul AE, Erbel R. Nephrogenic systemic fibrosis: pathogenesis, diagnosis, and therapy. J Am Coll Cardiol. 2009 May 5;53(18):1621-8. doi: 10.1016/j.jacc.2008.12.061.
PubMed 19406336Stojanov D, Aracki-Trenkic A, Benedeto-Stojanov D. Gadolinium deposition within the dentate nucleus and globus pallidus after repeated administrations of gadolinium-based contrast agents-current status. Neuroradiology. 2016 May;58(5):433-41. doi: 10.1007/s00234-016-1658-1. Epub 2016 Feb 12.
PubMed 26873830Roberts DR, Holden KR. Progressive increase of T1 signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images in the pediatric brain exposed to multiple doses of gadolinium contrast. Brain Dev. 2016 Mar;38(3):331-6. doi: 10.1016/j.braindev.2015.08.009. Epub 2015 Sep 4.
PubMed 26345358Hu HH, Pokorney A, Towbin RB, Miller JH. Increased signal intensities in the dentate nucleus and globus pallidus on unenhanced T1-weighted images: evidence in children undergoing multiple gadolinium MRI exams. Pediatr Radiol. 2016 Oct;46(11):1590-8. doi: 10.1007/s00247-016-3646-3. Epub 2016 Jun 9.
PubMed 27282825Finn JP, Nguyen KL, Hu P. Ferumoxytol vs. Gadolinium agents for contrast-enhanced MRI: Thoughts on evolving indications, risks, and benefits. J Magn Reson Imaging. 2017 Sep;46(3):919-923. doi: 10.1002/jmri.25580. Epub 2017 Feb 3. No abstract available.
PubMed 28160356Finn JP, Nguyen KL, Han F, Zhou Z, Salusky I, Ayad I, Hu P. Cardiovascular MRI with ferumoxytol. Clin Radiol. 2016 Aug;71(8):796-806. doi: 10.1016/j.crad.2016.03.020. Epub 2016 May 21.
PubMed 27221526
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus in Patients With Ventricular Aneurysm and After Percutaneous Ventricular Reconstruction
- ClinicalTrials.gov ID
- NCT06146751
- Acronym / sponsor ID
- 024
- Conditions
- Heart Aneurysm
- Keywords
- ferumoxytol, ultrasmall superparamagnetic iron oxide particles, contrast-enhanced magnetic resonance, thrombosis, ventricular aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 27 Nov 2023 (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.
The incidence of thrombosis in ventricular aneurysm was reported to be 35%-40%, which may lead to systemic thromboembolism. Patients with ventricular aneurysm without detectable thrombus are not routinely treated with anticoagulation. Therefore, the accuracy of intracardiac thrombus detection has an important impact on clinical management decisions. Currently, transthoracic echocardiography is the most commonly used method to detect intracardiac thrombus, but its sensitivity and positive predictive value are low. Cardiac magnetic resonance has a higher diagnostic accuracy for intracardiac thrombus, and its sensitivity and positive predictive value are higher than those of transthoracic echocardiography and CT. However, the gadolinium-based contrast agents commonly used for enhanced magnetic resonance imaging have some problems such as nephrogenic systemic fibrosis, gadolinium deposition in the brain, and short imaging time. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, can be used for off-label enhanced magnetic resonance imaging. Its long intravascular half-life makes it suitable for enhanced magnetic resonance imaging with complex scanning procedures and long repetitive scans. Ferumoxytol is cleared from the blood pool by macrophages of the reticuloendothelial system, mainly in the spleen and lymph nodes. Therefore, ferumoxytol has a favourable safety even in adults and children with end-stage renal failure. The aim of this study is to evaluate the effectiveness of a novel ferumoxytol-enhanced cardiac magnetic resonance in detecting intracardiac thrombus in patients with ventricular aneurysm and after percutaneous ventricular reconstruction.
Detailed description
Ferumoxytol is a member of ultrasmall superparamagnetic iron oxide particles with an average diameter of 30 nm, originally developed as an intravascular contrast agent for MRI. Ferumoxytol was approved by the FDA in 2009 for the intravenous treatment of iron deficiency anaemia in adults with chronic kidney disease, and has also been used off-label as a non-gadolinium contrast agent for whole-body magnetic resonance imaging. Its iron oxide core is coated with dextran, which reduces immunogenicity and delays phagocytosis and the release of elemental iron from the core. As a result, ferumoxytol has a long intravascular half-life of approximately 15 hours and is slowly taken up by the macrophages of the reticuloendothelial system. Because of its long half-life, ferumoxytol is suitable for enhanced magnetic resonance imaging with complex scanning procedures and long repetitive scans. Ferumoxytol has been proved to be safe even in adults and children with end-stage renal failure. As feraheme is not available in the Chinese market, we experimentally synthesised a new formulation of ferumoxytol, which is identical to ferumoxytol in terms of physicochemical structure, pharmacokinetics and toxicological effects, at the request of Chia Tai Tianqing Pharmaceutical Group Co, Ltd (Nanjing, China) in 2014. This study is a single-centre, prospective, observational, non-randomised study. The study will enrol patients with ventricular aneurysm and after percutaneous ventricular reconstruction. The aim of this study is to evaluate the effectiveness of ferumoxytol-enhanced cardiac magnetic resonance imaging in detecting intracardiac thrombus in patients with ventricular aneurysm and left ventricular thrombus in the dynamic chamber and static chamber in patients 180±30 days after percutaneous ventricular reconstruction by comparing the detection rate of intracardiac thrombus with ferumoxytol-enhanced cardiac magnetic resonance imaging and transthoracic echocardiography, and to provide a clinical basis for the development and application of the new generation of magnetic resonance contrast agents in China. The echocardiography and magnetic resonance imaging experts were blinded to each other's results.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with ventricular aneurysm and after percutaneous ventricular reconstruction | – | Drug: Superparamagnetic Iron Oxide NanoparticlesPatients with ventricular aneurysm and after percutaneous ventricular reconstruction undergo a novel ferumoxytol-enhanced cardiac magnetic resonance imaging and transthoracic echocardiography. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 patients with ventricular aneurysm and 10 to 20 patients after percutaneous ventricular reconstruction at the First Affiliated Hospital of Nanjing Medical University
Key inclusion criteria (3 listed)
- Age ≥ 18 years and ≤ 80 years;
- Patients with left ventricular aneurysm detected by transthoracic echocardiography or 180±30 days after percutaneous ventricular reconstruction;
- An informed consent form was signed voluntarily by the patients or an authorised family member.
Key exclusion criteria (7 listed)
- Patients unable to lie down for any reason;
- Patients who are unable to undergo MRI for psychological (e.g. suffering from claustrophobia syndrome) or physical reasons (e.g. non-antimagnetic metal retention in the body, hearing impairment, involuntary body movements, etc.);
- Patients with a known history of iron allergy or hypersensitivity;
- Patients taking other oral or intravenous iron products;
- Patients with haemosiderin deposition or haemochromatosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superparamagnetic Iron Oxide NanoparticlesAlso: ferumoxytolPatients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging. | Drug | patients with ventricular aneurysm and after percutaneous ventricular reconstruction |
Primary outcome
detection rate of intracardiac thrombus
Time frame: Nov. 1st, 2023 to Mar. 31st, 2025
Detection rate of intracardiac thrombus by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography
detection rate of thrombus in dynamic chamber and static chamber
Time frame: Nov. 1st, 2023 to Mar. 31st, 2025
Detection rate of thrombus in dynamic chamber and static chamber by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography in patients after percutaneous ventricular reconstruction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 23151669Delewi R, Zijlstra F, Piek JJ. Left ventricular thrombus formation after acute myocardial infarction. Heart. 2012 Dec;98(23):1743-9. doi: 10.1136/heartjnl-2012-301962. No abstract available.
- Background: PubMed 35386778El Ouazzani J, Jandou I. Aneurysm and pseudoaneurysm of the left ventricle. Ann Med Surg (Lond). 2022 Feb 24;75:103405. doi: 10.1016/j.amsu.2022.103405. eCollection 2022 Mar.
- Background: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
- Background: PubMed 23247304O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013 Jan 29;127(4):e362-425. doi: 10.1161/CIR.0b013e3182742cf6. Epub 2012 Dec 17. No abstract available.
- Background: PubMed 31820132Whalen H, Dako F, Patel P, Sahbaz J, Hong-Zohlman S, White CS, Jeudy J. Role of Imaging for Suspected Cardiac Thrombus. Curr Treat Options Cardiovasc Med. 2019 Dec 9;21(12):81. doi: 10.1007/s11936-019-0792-6.
- Background: PubMed 34928322Allard L, Bernhard B, Windecker S, Valgimigli M, Grani C. Left ventricular thrombus in ischaemic heart disease: diagnosis, treatment, and gaps of knowledge. Eur Heart J Qual Care Clin Outcomes. 2022 Aug 17;8(5):496-509. doi: 10.1093/ehjqcco/qcab097.
- Background: PubMed 16824834Srichai MB, Junor C, Rodriguez LL, Stillman AE, Grimm RA, Lieber ML, Weaver JA, Smedira NG, White RD. Clinical, imaging, and pathological characteristics of left ventricular thrombus: a comparison of contrast-enhanced magnetic resonance imaging, transthoracic echocardiography, and transesophageal echocardiography with surgical or pathological validation. Am Heart J. 2006 Jul;152(1):75-84. doi: 10.1016/j.ahj.2005.08.021.
- Background: PubMed 18632533Wertman R, Altun E, Martin DR, Mitchell DG, Leyendecker JR, O'Malley RB, Parsons DJ, Fuller ER 3rd, Semelka RC. Risk of nephrogenic systemic fibrosis: evaluation of gadolinium chelate contrast agents at four American universities. Radiology. 2008 Sep;248(3):799-806. doi: 10.1148/radiol.2483072093. Epub 2008 Jul 15.
- Background: PubMed 17267695Sadowski EA, Bennett LK, Chan MR, Wentland AL, Garrett AL, Garrett RW, Djamali A. Nephrogenic systemic fibrosis: risk factors and incidence estimation. Radiology. 2007 Apr;243(1):148-57. doi: 10.1148/radiol.2431062144. Epub 2007 Jan 31.
- Background: PubMed 19406336Kribben A, Witzke O, Hillen U, Barkhausen J, Daul AE, Erbel R. Nephrogenic systemic fibrosis: pathogenesis, diagnosis, and therapy. J Am Coll Cardiol. 2009 May 5;53(18):1621-8. doi: 10.1016/j.jacc.2008.12.061.
- Background: PubMed 26873830Stojanov D, Aracki-Trenkic A, Benedeto-Stojanov D. Gadolinium deposition within the dentate nucleus and globus pallidus after repeated administrations of gadolinium-based contrast agents-current status. Neuroradiology. 2016 May;58(5):433-41. doi: 10.1007/s00234-016-1658-1. Epub 2016 Feb 12.
- Background: PubMed 26345358Roberts DR, Holden KR. Progressive increase of T1 signal intensity in the dentate nucleus and globus pallidus on unenhanced T1-weighted MR images in the pediatric brain exposed to multiple doses of gadolinium contrast. Brain Dev. 2016 Mar;38(3):331-6. doi: 10.1016/j.braindev.2015.08.009. Epub 2015 Sep 4.
- Individual participant dataSharing planned: No
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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.
Chunjian Li, MD, PhD principal investigator
The First Affiliated Hospital with Nanjing Medical University
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 Heart Aneurysm, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 23 Sep 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 China. 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 Chunjian Li, MD, PhD (+86-13701465229, lijay@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection rate of intracardiac thrombus (time frame: Nov. 1st, 2023 to Mar. 31st, 2025). The study lists 2 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 NCT06146751, which also lists 23 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 23 Sep 2024.