Clinical trial NCT00849108
Conditions: Ischemia
Keywords: Myocardial Perfusion PET imaging SPECT imaging Coronary artery disease Subjects that are male and nonpregnant female patients presenting with reversible ischemia as characterized by a rest/stress SPECT imaging study using Technetium(99mTc)-labeled tracers
Sponsor: Lantheus Medical Imaging
Start date: 2009-01-01; Completion date: 2010-06-01
Enrollment: 176 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to get more information on using BMS747158 (the study drug),a drug with small amounts of radioactivity to allow for heart imaging, during a PET scan which can then be compared to other images such as SPECT. The safety and quality of images will be studied.

Detailed description:
The primary objectives of this study are:

* To acquire data for the development of one-day rest/stress cardiac PET perfusion imaging protocols for BMS747158 with comparable diagnostic image quality to a two-day rest/stress PET protocol
* To assess the safety of multiple doses of BMS747158

The secondary objectives of this study are:

* To assess PET imaging parameters and image quality following administration of BMS747158 at rest and at stress (pharmacologic or exercise) same day (at different time intervals) and 16-48 hours after the rest injection
* To assess feasibility of gated cardiac PET imaging with BMS747158 for left ventricular function assessment
* To assess agreement of one and two day rest/stress PET imaging with BMS747158 in patients with reversible ischemia with rest/stress single photon emission computed tomography (SPECT) imaging
* To perform a preliminary assessment of the diagnostic accuracy of one-day and two-day rest/stress PET perfusion imaging with BMS747158 as compared with invasive coronary angiography or computed tomography angiography (CTA) for detection of

Arms: arm 1: Patients to receive either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during pharmacological or exercise stress, over a 1-day or 2-day period. arm 2: Patients to receive 2 IV bolus injections of BMS747158:1 at rest and 1 at stress

For the Pharmacologic (Adenosine) Stress:

* Doses at rest to range between 2.9 and 3.4 mCi.
* Doses under stress to be a factor of 2.0 to 2.4 greater than the rest dose, resulting in a range of stress doses between 5.8 and 8.2 mCi.

For the Exercise Stress:

* Doses at rest were to range between 1.7 and 2.0 mCi.
* Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi.
Interventions: intervention 1: BMS747158
Intervention descriptions: intervention 1: dosages at rest and at stress were not to exceed a total of 14 mCi.

Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period.

Cohort 2: Patients to recieve IV bolus injections of BMS747158:

For the Pharmacologic (Adenosine) Stress:

* Doses at rest were to range between 2.9 and 3.4 mCi.
* Doses under stress were to be a factor of 2.0 to 2.4 greater than the rest dose, resulting in a range of stress doses between 5.8 and 8.2 mCi.

For the Exercise Stress:

* Doses at rest were to range between 1.7 and 2.0 mCi.
* Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi.

Protocol documents: