Efficacy and Saftey Study of 99mTc-ECDG in the Evaluation of Coronary Artery Disease (CAD)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Cell>Point LLC
ClinicalTrials.gov Identifier:
NCT01899833
First received: July 10, 2013
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

This study will compare how well a new radiolabeled imaging agent ECDG compares to the current testing for coronary artery disease (radiolabeled Sestamibi) during a rest and stress cardiac test as documented from results of a coronary angiogram (if performed).


Condition Intervention Phase
Coronary Artery Disease
Radiation: 99mTc-ECDG
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Prospective, Open-label, Multicenter Study With Blinded Over-reading Characterizing the Efficacy and Safety of 99mTc-EC-DG in the Evaluation of Coronary Artery Disease (CAD)

Resource links provided by NLM:


Further study details as provided by Cell>Point LLC:

Primary Outcome Measures:
  • Efficacy: Characterization of the efficacy of 99mTCc-ECDG in the evaluation of Coronary Artery Disease [ Time Frame: Visit 1a through Visit 3 approximately 3 to 20 days ] [ Designated as safety issue: No ]

    1. Determine efficacy (sensitivity and specificity) of 99mTc-ED-DG: i. Compare efficacy of a rest and stress study at approximately 15 minutes post injection compared with efficacy of a standard 99mTc-SPECT rest/stress perfusion study for detecting the presence of CAD using invasive coronary angiography as the truth standard.* ii. Compare efficacy of a rest and stress study at approximately 60 minutes post injection compared with a standard 99mTc-SPECT rest/stress perfusion study for detecting the presence of CAD using invasive coronary angiography as the truth standard.*

    * Images will be displayed using the standard Cedars Sinai tomographic display software which projects images in the short axis, vertical long, and horizontal long axis displays.



Secondary Outcome Measures:
  • Safety: The number of participants with Adverse Events [ Time Frame: From screeniing through up to 14 days after last study related procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 99mTc-EC-DG, Diagnostic
99mTc-EC-DG (25 ± 5 mCi, up to 250 µg EC-DG) will be administered by intravenous (IV) bolus injection.
Radiation: 99mTc-ECDG
An injection of 99mTC-ECDG with a target amount of 25 mCi with no more than 250 micrograms of ECDG will be administered by IV push under medically observed conditions.
Other Name: Technetium-99m-labeled Ethylenedicysteine-Deoxyglucose

Detailed Description:

This study will be a prospective, open-label, multi-center study assessing the efficacy and safety of 99mTc-EC-DG compared to 99mTc-SPECT MPI imaging for detecting the presence, location, and severity of CAD as established by coronary angiography. Approximately 60 patients will be enrolled in the study.

Group 1 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method (nuclear, ultrasound, CTA, MRI, etc.) and their physician has planned for coronary angiography but angiography has not yet been performed. In addition, the patient has not had coronary artery bypass graft (CABG). These patients can be enrolled.

Group 2 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method (nuclear, ultrasound, CTA, MRI, etc.) and the patient has already had coronary angiography performed but has not received any coronary intervention subsequent to the procedure.

The following sequence of imaging procedures will be performed for both Group 1 and 2 patients: The first procedure will be a 99mTc-EC-DG rest study. This will be followed within 24 hours to 3 days with a 1-day protocol 99mTc-SPECT MPI rest/stress study. This will be followed within 24 hours to 3 days with a 99mTc-EC-DG stress study.

For both Group 1 and 2, if 1 of the diagnostic imaging procedures performed to evaluate the presence of CAD was a traditional 99mTc-SPECT MPI rest/stress study, this procedure must be repeated as 1 of the 3 SPECT imaging procedures required by the trial protocol.

The modality for provocative stress testing (exercise, pharmacologic, or exercise/pharmacologic) will be matched between the 99mTc-SPECT study and the 99mTc-EC-DG study. All prospectively performed 99mTc-EC-DG and 99mTc-SPECT studies will be conducted using regadenoson as the pharmacologic stress agent. All imaging studies (99mTc-EC-DG, 99mTc-SPECT, coronary angiography) will be over-read by blinded, trained reviewers. The consensus blinded read will determine and record the location of the CAD by relating the wall of the myocardium affected to include: anterior, Inferior, lateral, septal and apex. The angiography study will identify the arteries associated with the CAD; namely, left anterior descending, circumflex or right coronary arteries. The study will also determine the severity of the CAD by visually comparing the size and intensity of the ischemic signal on rest and stress images obtained approximately 15 and 60 minutes post injection.

The results from the consensus blinded read of coronary angiography will be considered truth for the presence, location, and severity of obstructive CAD and degree of stenosis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years
  2. Either of the following:

    1. Standard 99mTc-SPECT perfusion rest/stress study completed within 30 days prior to screening and a coronary angiography study is clinically planned after the 99mTc-C-DG rest and stress visits in this study
    2. Coronary angiography study planned or completed within 30 days of screening and no coronary intervention has been performed and willingness to complete a standard 99mTc-SPECT rest/stress study
  3. The patient is able to provide informed consent to participate in this study
  4. No change in medical therapy between study procedures.

Exclusion Criteria:

  1. Known cardiomyopathy or history of congestive heart failure (CHF) due to left ventricular systolic dysfunction (ejection fraction < 40%)
  2. Starting a new anti-anginal drug or performance of revascularization prior to completing the 99mTc-EC-DG rest and stress study visits
  3. Contraindication for provocative stress testing based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise or pharmacologic testing
  4. Intolerance or inability to receive sestamibi, tetrofosmin, or regadenoson, or an inability or unwillingness to exercise on a graded treadmill or receive pharmacologic stress
  5. Inability to lie still for approximately 30 minutes during image acquisition
  6. 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), abstinence, or a partner with non-reversed vasectomy > 40 days prior to entry.
  7. Pregnant or nursing
  8. History of malignant disease (excluding treated basal cell or squamous cell carcinoma of skin, or low grade cancers that are stable and not interfering with exercise 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
  9. 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
  10. A known allergy to 99mTc-EC-DG or its components
  11. 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
  12. Received an investigational drug within 30 days prior to this study
  13. Prior bypass surgery
  14. Enrolled or plans to enroll in another clinical trial during this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01899833

Locations
United States, Oklahoma
Tom Hennebry, MD
Oklahoma City, Oklahoma, United States, 73210
Sponsors and Collaborators
Cell>Point LLC
Investigators
Principal Investigator: Gary Heller, MD Consultant
  More Information

No publications provided

Responsible Party: Cell>Point LLC
ClinicalTrials.gov Identifier: NCT01899833     History of Changes
Other Study ID Numbers: CP-ECDG-C3
Study First Received: July 10, 2013
Last Updated: March 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cell>Point LLC:
Coronary Artery Disease
CAD

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Deoxyglucose
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014