Trial Outcomes & Findings for Community Hospital Identification of High CV Risk Patients During Cancer Treatment (NCT NCT02566109)

NCT ID: NCT02566109

Last Updated: 2019-05-08

Results Overview

To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: Baseline, 2 months, and 6 months
• Results posted on: 2019-05-08

Participant Flow

Participant milestones

Measure	Fast MRI All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Fast MRI All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

1 patient did not receive baseline MRI

Baseline characteristics by cohort

Measure	Fast MRI n=6 Participants All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
Age, Continuous	45.1 years STANDARD_DEVIATION 15.3 • n=6 Participants
Sex: Female, Male Female	5 Participants n=6 Participants
Sex: Female, Male Male	1 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=6 Participants
Race (NIH/OMB) White	6 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Left Ventricular Ejection Fraction (LVEF)	61.51 percentage of fluid expelled STANDARD_DEVIATION 5.45 • n=5 Participants • 1 patient did not receive baseline MRI
End Diastolic Volume (EDV) - Magnetic Resonance Imaging (MRI)	134.90 mL STANDARD_DEVIATION 41.70 • n=5 Participants • 1 patient did not receive baseline MRI
End Systolic Volume (ESV) - Magnetic Resonance Imaging (MRI)	52.23 mL STANDARD_DEVIATION 18.91 • n=5 Participants • 1 patient did not receive baseline MRI
Pulse Wave Velocity (PWV) - Magnetic Resonance Imaging (MRI)	4.74 meters/sec STANDARD_DEVIATION 1.75 • n=5 Participants • 1 patient did not receive baseline MRI
Left Ventricular Ejection Fraction (LVEF) - Echocardiogram (ECHO)	54.17 percentage of fluid expelled STANDARD_DEVIATION 7.03 • n=6 Participants
End Diastolic Volume (EDV) - Echocardiogram (ECHO)	100.08 mL STANDARD_DEVIATION 24.20 • n=6 Participants
End Systolic Volume (ESV) - Echocardiogram (ECHO)	44.90 mL STANDARD_DEVIATION 9.16 • n=6 Participants

PRIMARY outcome

Timeframe: Baseline, 2 months, and 6 months

Population: Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.

To compare baseline, 2-month (using Fast MRI), and 6 month measures in left ventricular (LV) ejection fraction

Outcome measures

Measure	Fast MRI n=5 Participants All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months 2 months FAST MRI	56.67 percentage of fluid ejected Standard Deviation 4.71
Left Ventricular Ejection Fraction (LVEF) at Baseline, 2 Month Using Fast MRI, and 6 Months 6 months	58.69 percentage of fluid ejected Standard Deviation 3.28

PRIMARY outcome

Timeframe: Baseline, 2 months, and 6 months

Population: Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.

To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Diastolic Volume (EDV)

Outcome measures

Measure	Fast MRI n=5 Participants All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months 2 months FAST MRI	126.07 mL Standard Deviation 32.36
End Diastolic Volume (EDV) at Baseline, 2 Month, and 6 Months 6 months	130.20 mL Standard Deviation 44.52

PRIMARY outcome

Timeframe: Baseline, 2 months, and 6 months

Population: Only 5 received MRI at baseline, 4 at 2 months using Fast MRI, and 3 at 6 months.

To compare baseline, 2-month (using Fast MRI), and 6 month measures in end Systolic Volume (ESV)

Outcome measures

Measure	Fast MRI n=5 Participants All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months 2 months FAST MRI	54.72 mL Standard Deviation 14.52
End Systolic Volume (ESV) at Baseline, 2 Month, and 6 Months 6 months	54.73 mL Standard Deviation 23.11

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: Only 5 received MRI at baseline and 3 at 6 months.

To compare baseline and 6 month measures in pulse wave velocity (PWV)

Outcome measures

Measure	Fast MRI n=5 Participants All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
Pulse Wave Velocity (PWV) at Baseline and 6 Months Baseline	4.74 Meters/sec Standard Deviation 1.75
Pulse Wave Velocity (PWV) at Baseline and 6 Months 6 months	4.07 Meters/sec Standard Deviation 1.70

SECONDARY outcome

Timeframe: Baseline

Population: All 6 participants that received both an ECHO. Only 5 had an MRI at baseline

To compare Magnetic Resonance Imaging (MRI) metric of Left Ventricular Ejection Fraction (LVEF) with Echocardiogram (ECHO) at baseline

Outcome measures

Measure	Fast MRI n=6 Participants All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
Left Ventricular Ejection Fraction (LVEF): Comparison of Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline LVEF Echo	54.17 percentage of fluid expelled Standard Deviation 7.03
Left Ventricular Ejection Fraction (LVEF): Comparison of Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline LVEF MRI	61.51 percentage of fluid expelled Standard Deviation 5.45

SECONDARY outcome

Timeframe: Baseline

Population: All 6 participants that received both an ECHO. Only 5 had an MRI at baseline

To compare magnetic resonance imaging (MRI) metric of End Diastolic Volume (EDV) with echocardiogram (ECHO) at baseline

Outcome measures

Measure	Fast MRI n=6 Participants All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
End Diastolic Volume (EDV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline EDV Echo	100.08 mL Standard Deviation 24.20
End Diastolic Volume (EDV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline EDV MRI	134.90 mL Standard Deviation 41.70

SECONDARY outcome

Timeframe: Baseline

Population: All 6 participants that received both an ECHO. Only 5 had an MRI at baseline

To compare magnetic resonance imaging (MRI) metric of End Systolic Volume (ESV) with echocardiogram (ECHO) at baseline

Outcome measures

Measure	Fast MRI n=6 Participants All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
End Systolic Volume (ESV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline ESV Echo	44.90 mL Standard Deviation 9.16
End Systolic Volume (ESV): Compare Magnetic Resonance Imaging (MRI) With Echocardiogram (ECHO) at Baseline ESV MRI	52.23 mL Standard Deviation 18.91

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

To use exploratory algorithmic modeling to obtain optimal strategies for determining the combination of metrics (10-min MR, ECHO, serum biomarkers) at 2-months that predict the 6-month post Chemotherapy deteriorations in cardiovascular function.

Outcome measures

Outcome data not reported

Adverse Events

Fast MRI

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Fast MRI n=6 participants at risk All patients who agree to participate in this study will have a 10 minute fast MRI scan and Baseline and 6 month time periods. The fast MRI will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment. Fast MRI: The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
Infections and infestations Febrile neutropenia	16.7% 1/6 • Number of events 1 • From time of signed informed consent to 30 days post study completion for each participant. Study completion was approximately 6 months. Grades 1, 2, and 3 expected (solicited) and unexpected (unsolicited) adverse events (AE)s that meet the above definition for an AE and are only definitely related, possibly related or probably related to this study intervention should be reported using the Toxicity Assessment Sheet. Hospitalizations that are scheduled for routine treatments and procedures unrelated to study intervention do not need to be reported. All toxicities are graded using CTCAE v4.03.
Nervous system disorders Headache	16.7% 1/6 • Number of events 1 • From time of signed informed consent to 30 days post study completion for each participant. Study completion was approximately 6 months. Grades 1, 2, and 3 expected (solicited) and unexpected (unsolicited) adverse events (AE)s that meet the above definition for an AE and are only definitely related, possibly related or probably related to this study intervention should be reported using the Toxicity Assessment Sheet. Hospitalizations that are scheduled for routine treatments and procedures unrelated to study intervention do not need to be reported. All toxicities are graded using CTCAE v4.03.

Additional Information

Gregory Hundley, MD

Wake Forest University Health Sciences

Phone: 336-716-0607

Email: ghundley@wakehealth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place