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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03760237
Other study ID # UPCC48418
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 10, 2018
Est. completion date May 6, 2024

Study information

Verified date May 2024
Source Abramson Cancer Center at Penn Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

An observational, prospective study to describe the rates and predictors of cardiovascular events in patients with acute leukemia.


Description:

Patients recently diagnosed with acute leukemia and who will initiating chemotherapy will be enrolled and followed serially with blood collection, echocardiogram, arterial applanation tonometry, and questionnaires for 1 year.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date May 6, 2024
Est. primary completion date May 6, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Older than 18 years of age, - New diagnosis of untreated acute leukemia (prior treatment for myelodysplastic syndrome or myeloproliferative neoplams or prior treatment with an anthracycline for breast cancer, Hodgkin's lymphoma, non-Hodgkin's lymphoma or another diagnosis will be included). - Signed the informed consent form Exclusion Criteria: • Unable to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
observation only
No intervention, observational study only

Locations

Country Name City State
United States Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Left Ventricular dysfunction defined as a reduction in Left Ventricular Ejection Fraction of more than 10 percentage points from baseline and to less than 50%. 1 year
Secondary Incidence of Cardiovascular Events 1 year
Secondary Incidence of Symptomatic Heart Failure 1 year
Secondary Incidence of Cardiac Death and all mortality 1 year
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