Registry for CARDIAC PERFUSION CT (RECRUIT)

This study has been withdrawn prior to enrollment.
(No funding)
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
MDDX LLC
ClinicalTrials.gov Identifier:
NCT01346605
First received: April 30, 2011
Last updated: December 8, 2012
Last verified: December 2012
  Purpose

This protocol describes a study whose goal is to collect de-identified Cardiac CT Perfusion (CTP) acquisition parameters and clinical findings from approximately 20 qualified medical facilities. The study uses an electronic data capture tool to collect the de-identified data to create a global multi-center registry. This registry will be used for scientific analysis and publication of pertinent medical trends such as CT utilization, radiation dose, and common cardiovascular findings.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Registry for CARDIAC PERFUSION CT

Resource links provided by NLM:


Further study details as provided by MDDX LLC:

Primary Outcome Measures:
  • Best Practices for CTP [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Collect DICOM cases and determine the best practices for CTP, including radiation dose, image quality and patient comfort


Enrollment: 0
Study Start Date: May 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
CCTA patients
Prior stress SPECT with intermediate to high likelihood to be referred to the cardiac catheterization laboratory for an invasive coronary angiogram or patients presenting with chest pain and clinical indication of Coronary CT Angiography and an initial calcium score above 300

Detailed Description:

The recently developed technique of Cardiac CT Perfusion (CTP) gathers information on both coronary anatomy and myocardial perfusion in a single scan. This diagnostic test can detect the presence of coronary plaque as well as assess the functional significance of a stenosis. To date, it is estimated that 1000 cases of CTP have been performed in the world. While no exceptional adverse events have been reported (nor are expected), the image quality and clinical validation in a multi-center multi-vendor setting has been a marked issue for many experts in this nascent field. This issue has hampered the clinical utility of this test and raises concerns about its widespread utilization leading to unnecessary costs and exposure to radiation.

Historically, the rapid explosion in the use of a related procedure, Cardiac CT Angiography (CCTA) started in 2004 and was marked by large-scale variation in radiation dose, quality issues, inappropriate use, and interpretation proficiency. Critics of the rapid growth of CCTA defamed the procedure for imaging abuse charges and noted unchecked and irresponsible use radiation.

The purpose of RECRUIT is to prevent this clinical inefficiency from occurring again. The main goal of RECRUIT is to determine the best practices for optimal acquisition and interpretation of the CTP images, in an effort to optimize standards before the inevitable rapid adoption of this potentially revolutionary technology. RECRUIT will aim to maximize the clinical effectiveness and minimize the clinical risks associated with CTP before the protocol becomes integrated into the standard-of-care and harmonization of the best practices is nearly impossible.

RECRUIT will enable select clinics that are currently performing CCTA to perform CTP by training them on the latest acquisition techniques as provided by the field leaders in CTP. In addition to providing the acquisition protocol, our researchers will provide the clinical team with a sophisticated EDC tool that effectively monitors numerous factors that could influence the quality of the images. Finally, RECRUIT will collect de-identified images from the sites for analysis in our core lab. Analysis of the images will be correlated with acquisition techniques and patient factors (i.e. BMI). This information fed back to the clinical team that performed the procedure in an effort to improve their proficiency. This process will proceed in an iterative manner, with all endpoints being tracked for reporting in peer-reviewed literature.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Prior stress SPECT with intermediate to high likelihood to be referred to the cardiac catheterization laboratory for an invasive coronary angiogram or patients presenting with chest pain and clinical indication of Coronary CT Angiography and an initial calcium score above 300

Criteria

Inclusion Criteria:

  • Moderate-high likelihood of coronary artery disease with a prior stress SPECTMPI exam likely to be referred to the cardiac catheterization laboratory for invasive angiogram or patients presenting with clinical indication of Coronary -CT Angiography and an initial calcium score above 300
  • Stable angina or anginal equivalent as the chief symptom.
  • Age > 34 years old
  • Able to comprehend and sign the consent form.

Exclusion Criteria:

  • BMI<41
  • Acute coronary syndromes (unstable angina, non-ST elevation myocardial infarction, ST elevation myocardial infarction)
  • Unstable clinical conditions (i.e. hemodynamic instability, arrhythmias)
  • Premenopausal women who have menstruated in the last year
  • Glomerular Filtration Rate (GFR) < 60 ml/min/BSA as an indicator of renal insufficiency
  • Known allergy to iodinated contrast agents
  • Patients who are on metformin medication for any reason
  • Atrial fibrillation
  • Asthma
  • Critical aortic stenosis
  • Systolic blood pressure < 90 mmHg
  • Advanced heart block
  • Pacemaker or AICD
  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: NCT01346605

Locations
United States, Florida
Miami Baptist
Miami, Florida, United States, 33176
Sponsors and Collaborators
MDDX LLC
Astellas Pharma Inc
Investigators
Principal Investigator: Ricardo Cury, MD Miami Baptist
Study Chair: James Min, MD Cedars Sinai
  More Information

No publications provided

Responsible Party: MDDX LLC
ClinicalTrials.gov Identifier: NCT01346605     History of Changes
Other Study ID Numbers: RECRUIT Study
Study First Received: April 30, 2011
Last Updated: December 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by MDDX LLC:
Cardiac CT, heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014