Trial Outcomes & Findings for Stress CT Perfusion in Patients With Chest Pain (NCT NCT01969916)

NCT ID: NCT01969916

Last Updated: 2021-02-21

Results Overview

Perfusion defect on stress CT images obtained at peak effect of Regadenoson, in the presence of coronary stenosis \>50%.

Recruitment status

COMPLETED

Study phase

Target enrollment

150 participants

Primary outcome timeframe

At least 1 year

Results posted on

2021-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Regadenoson Regadenoson: Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
Overall Study STARTED	150
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	45

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	Regadenoson n=150 Participants Regadenoson: Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
Age, Continuous	55 years STANDARD_DEVIATION 11 • n=150 Participants
Sex: Female, Male Female	78 Participants n=150 Participants
Sex: Female, Male Male	72 Participants n=150 Participants
Region of Enrollment United States	150 participants n=150 Participants

PRIMARY outcome

Timeframe: At least 1 year

Perfusion defect on stress CT images obtained at peak effect of Regadenoson, in the presence of coronary stenosis \>50%.

Outcome measures

Outcome measures
Measure	Regadenoson n=150 Participants Regadenoson: Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
Number of Participants With Detected Stress-induced Perfusion Abnormalities by 3D Analysis of MDCT Images	56 Participants

Adverse Events

Regadenoson

Serious events: 0 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Regadenoson n=150 participants at risk Regadenoson: Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
Vascular disorders Flushing	29.3% 44/150 • Adverse effects of the drug (regadenoson) were monitored over 2 hours following administration. The drug is short-acting and is cleared within an even shorter time frame. In contrast, patient outcomes, which are not related to the above drug but to the existing disease, were collected over a follow-up period of at least 1 year (mean 36±25 months). These included all-cause mortality, myocardial infarction or coronary revascularization. Over the above follow-up period, there were adverse outcomes related to the disease (N=7), not to the drug. This was not a drug study aimed at evaluating the safety of regadenoson, but rather the feasibility and efficacy of a new diagnostic techniques, which included the relationship between its findings and outcomes.
Respiratory, thoracic and mediastinal disorders Dyspnea	26.7% 40/150 • Adverse effects of the drug (regadenoson) were monitored over 2 hours following administration. The drug is short-acting and is cleared within an even shorter time frame. In contrast, patient outcomes, which are not related to the above drug but to the existing disease, were collected over a follow-up period of at least 1 year (mean 36±25 months). These included all-cause mortality, myocardial infarction or coronary revascularization. Over the above follow-up period, there were adverse outcomes related to the disease (N=7), not to the drug. This was not a drug study aimed at evaluating the safety of regadenoson, but rather the feasibility and efficacy of a new diagnostic techniques, which included the relationship between its findings and outcomes.
Cardiac disorders Chest discomfort	12.7% 19/150 • Adverse effects of the drug (regadenoson) were monitored over 2 hours following administration. The drug is short-acting and is cleared within an even shorter time frame. In contrast, patient outcomes, which are not related to the above drug but to the existing disease, were collected over a follow-up period of at least 1 year (mean 36±25 months). These included all-cause mortality, myocardial infarction or coronary revascularization. Over the above follow-up period, there were adverse outcomes related to the disease (N=7), not to the drug. This was not a drug study aimed at evaluating the safety of regadenoson, but rather the feasibility and efficacy of a new diagnostic techniques, which included the relationship between its findings and outcomes.
Cardiac disorders Palpitations	10.7% 16/150 • Adverse effects of the drug (regadenoson) were monitored over 2 hours following administration. The drug is short-acting and is cleared within an even shorter time frame. In contrast, patient outcomes, which are not related to the above drug but to the existing disease, were collected over a follow-up period of at least 1 year (mean 36±25 months). These included all-cause mortality, myocardial infarction or coronary revascularization. Over the above follow-up period, there were adverse outcomes related to the disease (N=7), not to the drug. This was not a drug study aimed at evaluating the safety of regadenoson, but rather the feasibility and efficacy of a new diagnostic techniques, which included the relationship between its findings and outcomes.
Gastrointestinal disorders Abdominal discomfort	11.3% 17/150 • Adverse effects of the drug (regadenoson) were monitored over 2 hours following administration. The drug is short-acting and is cleared within an even shorter time frame. In contrast, patient outcomes, which are not related to the above drug but to the existing disease, were collected over a follow-up period of at least 1 year (mean 36±25 months). These included all-cause mortality, myocardial infarction or coronary revascularization. Over the above follow-up period, there were adverse outcomes related to the disease (N=7), not to the drug. This was not a drug study aimed at evaluating the safety of regadenoson, but rather the feasibility and efficacy of a new diagnostic techniques, which included the relationship between its findings and outcomes.
General disorders Headache	10.0% 15/150 • Adverse effects of the drug (regadenoson) were monitored over 2 hours following administration. The drug is short-acting and is cleared within an even shorter time frame. In contrast, patient outcomes, which are not related to the above drug but to the existing disease, were collected over a follow-up period of at least 1 year (mean 36±25 months). These included all-cause mortality, myocardial infarction or coronary revascularization. Over the above follow-up period, there were adverse outcomes related to the disease (N=7), not to the drug. This was not a drug study aimed at evaluating the safety of regadenoson, but rather the feasibility and efficacy of a new diagnostic techniques, which included the relationship between its findings and outcomes.
General disorders Dizziness	8.7% 13/150 • Adverse effects of the drug (regadenoson) were monitored over 2 hours following administration. The drug is short-acting and is cleared within an even shorter time frame. In contrast, patient outcomes, which are not related to the above drug but to the existing disease, were collected over a follow-up period of at least 1 year (mean 36±25 months). These included all-cause mortality, myocardial infarction or coronary revascularization. Over the above follow-up period, there were adverse outcomes related to the disease (N=7), not to the drug. This was not a drug study aimed at evaluating the safety of regadenoson, but rather the feasibility and efficacy of a new diagnostic techniques, which included the relationship between its findings and outcomes.
Gastrointestinal disorders Nausea	6.0% 9/150 • Adverse effects of the drug (regadenoson) were monitored over 2 hours following administration. The drug is short-acting and is cleared within an even shorter time frame. In contrast, patient outcomes, which are not related to the above drug but to the existing disease, were collected over a follow-up period of at least 1 year (mean 36±25 months). These included all-cause mortality, myocardial infarction or coronary revascularization. Over the above follow-up period, there were adverse outcomes related to the disease (N=7), not to the drug. This was not a drug study aimed at evaluating the safety of regadenoson, but rather the feasibility and efficacy of a new diagnostic techniques, which included the relationship between its findings and outcomes.
Cardiac disorders Chest pain	5.3% 8/150 • Adverse effects of the drug (regadenoson) were monitored over 2 hours following administration. The drug is short-acting and is cleared within an even shorter time frame. In contrast, patient outcomes, which are not related to the above drug but to the existing disease, were collected over a follow-up period of at least 1 year (mean 36±25 months). These included all-cause mortality, myocardial infarction or coronary revascularization. Over the above follow-up period, there were adverse outcomes related to the disease (N=7), not to the drug. This was not a drug study aimed at evaluating the safety of regadenoson, but rather the feasibility and efficacy of a new diagnostic techniques, which included the relationship between its findings and outcomes.

Additional Information

Victor Mor-Avi

University of Chicago

Phone: 773-702-7780

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place