Trial Outcomes & Findings for Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking (NCT NCT02130453)

Last Updated: 2024-10-02

Results Overview

As primary analysis, paired test of equivalence used for proportions proposed by Tango to test equivalence of the two ischemia tests among tSPECT positive patients.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

161 participants

Primary outcome timeframe

1 day

Results posted on

2024-10-02

Participant Flow

Patients were recruited from the cardiac stress laboratory at MD Anderson's main building between 9-30-2014 and 9-7-2018. Patients who were scheduled for a nuclear stress test using regadenoson were evaluated for eligibility and approached for participation in the study.

161 participants were approached for the study but 27 participants were excluded. The reasons for exclusion prior to inclusion in the study were as follows: poor quality echocardiographic images (24 patients), patient withdrew consent (2 patients), surgery canceled (1 patient)

Participant milestones

Participant milestones
Measure	Experimental: ReSTE Cardiac Imaging Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete.
Overall Study STARTED	134
Overall Study COMPLETED	134
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accuracy of an Echo-Stress Protocol Using Regadenoson With Speckle Tracking

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental: ReSTE Cardiac Imaging n=134 Participants Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete.
Age, Continuous	64.99 years STANDARD_DEVIATION 8.79 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	117 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants
Race (NIH/OMB) White	111 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	134 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

As primary analysis, paired test of equivalence used for proportions proposed by Tango to test equivalence of the two ischemia tests among tSPECT positive patients.

Outcome measures

Outcome measures
Measure	Experimental: ReSTE Cardiac Imaging n=134 Participants Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete.
Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia Positive RESTE proportion with positive angiogram	0.1538 proportion of participants Interval 0.0151 to 0.2925
Comparison of Accuracy of ReSTE Imaging to SPECT Imaging in Diagnosis of Ischemia Positive nuclear stress test proportion with positive angiogram	0.2308 proportion of participants Interval 0.0688 to 0.3928

SECONDARY outcome

Timeframe: 30 days

Population: Evaluation of cardiac events within 30 days of surgery for those patients who had SPECT for preoperative evaluation.

Cardiac events after ReSTE and SPECT imaging included myocardial infarction,heart failure, sudden cardiac death, cerebrovascular accident

Outcome measures

Outcome measures
Measure	Experimental: ReSTE Cardiac Imaging n=68 Participants Echocardiography strain measurement performed taking about 10 minutes. After resting strain measurement done, first set of nuclear images performed. Once these images are completed, participant given Regadenoson 0.4 mg by vein over about 10 seconds. Within 2 to 4 minutes of receiving the Regadenoson, measurements repeated. These measurements will take about 2 minutes to complete.
Cardiac Event Rates After ReSTE and SPECT Imaging	0 events

Adverse Events

Experimental: ReSTE Cardiac Imaging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicolas Palaskas, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 745-1942

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place