Trial Outcomes & Findings for Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET (NCT NCT01109992)

Last Updated: 2018-10-25

Results Overview

1. Count of subjects with ischemic ECG changes is reported 2. Count of subjects with systolic blood pressure decrease \> 20 mm Hg is reported 3. Count of subjects with abnormal serum troponin T levels is reported 4. Radiation dose to the staff will be measured using personal dosimeters after the Lexiscan as well as the Lexercise PET study.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

Day of the research scan during the stress test

Results posted on

2018-10-25

Participant Flow

43 subjects consented for the study and 41 subjects completed the study. One subject did not come for the study procedures. One subject could not cooperate with imaging and was moving during the rest scan. Regadenoson scan was not performed.

Participant milestones

Participant milestones
Measure	Regadenoson Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson Rubidium-82 Positron Emission Tomography	Exercise + Regadenoson Exercise plus Regadenoson Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
Overall Study STARTED	11	32
Overall Study Subjects Enrolled	11	32
Overall Study COMPLETED	11	30
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Regadenoson Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson Rubidium-82 Positron Emission Tomography	Exercise + Regadenoson Exercise plus Regadenoson Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
Overall Study Withdrawal by Subject	0	1
Overall Study Movement during rest scan.	0	1

Baseline Characteristics

Integrated Dual Exercise and Lexiscan Positron Emission Tomography: IDEALPET

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regadenoson n=11 Participants Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson: Regadenoson Rubidium-82 Positron Emission Tomography	Exercise + Regadenoson n=30 Participants Exercise plus Regadenoson Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson: Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography	Total n=41 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 11 • n=5 Participants	54 years STANDARD_DEVIATION 15 • n=7 Participants	57 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	16 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	22 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants	30 Participants n=7 Participants	41 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of the research scan during the stress test

Population: Radiation dose to staff was not measured due to logistical difficulties.Three subjects had blood pressure changes in the Regadenoson (Lexiscan) arm; 3 subjects showed ischemic ECG changes in the exercise + regadenoson (Lexercise) arm; and, none of the subjects showed abnormal troponin levels.

Outcome measures

Outcome measures
Measure	Regadenoson (Lexiscan) n=11 Participants Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography.	Exercise + Regadenoson (Lexercise) n=30 Participants Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
Safety and Tolerability of Combined Exercise and Regadenoson Stress Count of ischemic ECG changes	0 Participants	3 Participants
Safety and Tolerability of Combined Exercise and Regadenoson Stress Count of subjects systolic blood pressure decrease	3 Participants	0 Participants
Safety and Tolerability of Combined Exercise and Regadenoson Stress Count of subjects with abnormal troponin	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)

Sub-diaphragmatic activity: Heart to Liver Ratio was measured on the rubidium-82 and N-13 ammonia scans. Since this measure is a ratio it has no units. Mean and Standard Deviation of Ratio is reported for each group. This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.

Outcome measures

Outcome measures
Measure	Regadenoson (Lexiscan) n=11 Participants Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography.	Exercise + Regadenoson (Lexercise) n=30 Participants Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
Image Quality: Heart to Liver Ratio of Counts Stress Scan 1	1.23 mean ratio Standard Deviation 0.55	1.11 mean ratio Standard Deviation 0.58
Image Quality: Heart to Liver Ratio of Counts Stress Scan 2	1.25 mean ratio Standard Deviation 0.57	1.37 mean ratio Standard Deviation 0.82

SECONDARY outcome

Timeframe: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)

Left ventricular ejection fraction (LVEF) at stress was measured at Stress scan 1 (regadenoson) and Stress scan 2 (regadenoson or exercise + regadenoson). This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.

Outcome measures

Outcome measures
Measure	Regadenoson (Lexiscan) n=11 Participants Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography.	Exercise + Regadenoson (Lexercise) n=30 Participants Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET Stress 1 Scan	58 percentage of LVEF Standard Deviation 15	60 percentage of LVEF Standard Deviation 14
Changes in Left Ventricular Function With Dual Exercise and Regadenoson PET Stress 2 Scan	59 percentage of LVEF Standard Deviation 15	62 percentage of LVEF Standard Deviation 14

SECONDARY outcome

Timeframe: Week 1 (day of the clinical scan), and Week 2 (day of the research scan)

Population: Myocardial blood flow could not be accurately measured in one subject from each arm. Therefore we report information on 10/11 subjects in Regadenoson arm and 29/30 subjects in the Exercise + Regadenoson arm.

Myocardial Blood Flow Measured at Peak Hyperemia With Regadenoson or Immediately After Exercise + Regadenoson This was measured on the clinical scan and on the research scan which were performed about 2 weeks apart in most subjects.

Outcome measures

Outcome measures
Measure	Regadenoson (Lexiscan) n=10 Participants Regadenoson Rubidium-82 Positron Emission Tomography Regadenoson (Lexiscan): Regadenoson Rubidium-82 Positron Emission Tomography.	Exercise + Regadenoson (Lexercise) n=29 Participants Exercise plus Regadenoson (Lexercise) Rubidium-82 Positron Emission Tomography Exercise plus Regadenoson (Lexercise): Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
Peak Stress Myocardial Blood Flow Stress 1 Scan	1.82 mL/gm/min Standard Deviation 0.73	2.04 mL/gm/min Standard Deviation 0.58
Peak Stress Myocardial Blood Flow Stress 2 Scan	1.85 mL/gm/min Standard Deviation 0.85	2.34 mL/gm/min Standard Deviation 0.82

Adverse Events

Regadenoson (Lexiscan)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise + Regadenoson (Lexiscan)

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

Sharmila Dorbala

Brigham and Women's Hospital

Phone: 617-732-6215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place