A Single Center Study to Establish the Imaging Protocol of 99mTc-EC-DG in Evaluating the Presence and Severity of Coronary Artery Disease (CAD)

NCT01778218 | Completed Phase 2 DMC

• 1 other identifier: CP-ECDG-C2
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the safety and tolerability of the investigational radiolabeled imaging agent technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG). Additionally, the study will determine the specific times to best image the heart using a SPECT camera with the investigational imaging agent and compare the images to those taken while undergoing the standard rest and exercise/regadenoson testing previously performed to detect the presence and severity of Coronary Artery Disease (CAD).

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; CAD

Outcome Measures

Primary Outcomes (1)

• Safety: The number of participants with Adverse Events

  From screening through 7 days after Investigational Product administration

Study Arms (1)

99mTc-EC-DG

EXPERIMENTAL

99mTc-EC-DG injection followed by SPECT imaging during a cardiac rest study (Visit 1) and an exercise/regadenoson study (Visit 2)

Radiation: Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose

Interventions

Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose RADIATION

An injection of Technetium ethylenedicysteine-deoxyglucose (99mTc-EC-DG) to yield a target activity of 25 mCi (range of 10-25 mCi) with no more than 250 micrograms of EC-DG to be administered (there must be a minimum of 24 hours between Visit 1 and 2 administrations). Investigational Product to be given by IV push.

99mTc-EC-DG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Reversible perfusion defect indicative of CAD on a MIBI exercise/regadenoson study completed within 30 days prior to screening;
• When possible, a coronary angiography will be clinically planned; patient and treating physician must be agreeable to completing the angiogram after the 99mTc-EC-DG exercise/regadenoson study in order for the procedure to be performed.
• The patient is able to provide written informed consent to participate in this study

You may not qualify if:

• Known cardiomyopathy or history of congestive heart failure (CHF) due to left ventricular systolic dysfunction (ejection fraction \< 40%)
• A scheduled coronary angiogram that prevents the 99mTc-EC-DG exercise/regadenoson or rest study visits from being completed prior to the angiogram
• Plans to begin new anti-anginal therapy prior to completing the 99mTc-EC-DG rest/stress study visits
• Contraindication for provocative stress testing based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise or pharmacologic testing
• Intolerance or inability to receive sestamibi or regadenoson, or an inability or unwillingness to exercise on a graded treadmill or receive pharmacologic stress
• Inability to lie still for 30 minutes during image acquisition
• Women of childbearing potential, unless willing to use adequate contraception throughout the duration of the trial. Adequate contraception is considered hormonal contraception for \>3 months prior to entry, intrauterine device (IUD) in place for at least 3 months, double barrier methods (condoms, diaphragm or spermicide), or a partner with non-reversed vasectomy \> 40 days prior to entry.
• Pregnant (positive human chorionic gonadotropin \[hCG\]) pregnancy test at screening for women of childbearing potential) or nursing
• History of malignant disease (excluding treated basal cell or squamous cell carcinoma of skin, or low grade cancers that are stable and do not interfere with exercise which may be allowed with permission from the Medical Monitor) within 5 years prior to screening. Resolution of a prior malignancy more than 5 years prior to screening must be deemed as cured by the Investigator
• Any physical, psychological or substance abuse (drug or alcohol) condition which, in the opinion of the Investigator, would interfere with the ability to provide informed consent or comply with study instructions or may adversely affect the safety of the patient if enrolled in this trial
• A known allergy to 99mTc-EC-DG or its components
• Inability to adhere to requirements specific to the study site's protocols for imaging and exercise/pharmacological stress testing, including but not limited to, dietary restrictions and prohibited medications
• Received an investigational drug within 30 days prior to this study
• Enrolled in or plans to enroll in another clinical trial during this study

Sponsors & Collaborators

• Cell>Point LLC: lead

Study Sites (1)

Cardiovascular Imaging Technologies

Kansas City, Kansas, 64111, United States

Location

Related Links

• Sponsor Link

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Timothy Bateman, MD

  Cardiovascular Imaging Technologies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 29, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 12, 2013

Record last verified: 2013-07

Locations

US (1)