Trial Outcomes & Findings for Simultaneous Assessment of FFR and SPECT (NCT NCT02749045)

Results Overview

The concordance will be calculated as the percentage of patients who had an abnormal FFR (\<0.8) and an abnormal SPECT (a perfusion defect on the SPECT) PLUS patients who had a normal FFR (≥ 0.8) and a normal SPECT. concordance= patients with abnormal FFR and abnormal SPECT + patients with normal FFR and normal SPECT/ total no. of patients

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

24 hours

Results posted on

2022-02-02

Participant Flow

Recruitment was significantly affected by COVID-19 and the increasing use of iFR in place of FFR

Participant milestones

Participant milestones
Measure	Image Acquisition Arm Subjects who have undergone a clinically indicated fractional flow reserve measurement in the cardiac catheterization laboratory will receive standard dose Tc-99m sestamibi and undergo resting SPECT image acquisition within three hours from end of cardiac catheterization procedure. SPECT imaging: myocardial perfusion imaging
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Image Acquisition Arm n=27 Participants Subjects who have undergone a clinically indicated fractional flow reserve measurement in the cardiac catheterization laboratory will receive standard dose Tc-99m sestamibi and undergo resting SPECT image acquisition within three hours from end of cardiac catheterization procedure. SPECT imaging: myocardial perfusion imaging
Age, Categorical <=18 years	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=27 Participants
Age, Categorical >=65 years	17 Participants n=27 Participants
Age, Continuous	66.6 years STANDARD_DEVIATION 10.3 • n=27 Participants
Sex: Female, Male Female	13 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=27 Participants
Region of Enrollment United States	27 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours

The concordance will be calculated as the percentage of patients who had an abnormal FFR (\<0.8) and an abnormal SPECT (a perfusion defect on the SPECT) PLUS patients who had a normal FFR (≥ 0.8) and a normal SPECT. concordance= patients with abnormal FFR and abnormal SPECT + patients with normal FFR and normal SPECT/ total no. of patients

Outcome measures

Outcome measures
Measure	Image Acquisition Arm n=27 Participants Subjects who have undergone a clinically indicated fractional flow reserve measurement in the cardiac catheterization laboratory will receive standard dose Tc-99m sestamibi and undergo resting SPECT image acquisition within three hours from end of cardiac catheterization procedure. SPECT imaging: myocardial perfusion imaging
Concordance Between Gated SPECT Perfusion Data (QGS) and Fractional Flow Reserve (FFR)	19 Participants

Adverse Events

Image Acquisition Arm

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

Prem Soman, MD, PhD

University of Pittsburgh Medical Center

Phone: 412 647 3435

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place