Registry for CARDIAC PERFUSION CT

NCT01346605 | Withdrawn DMC

• 1 other identifier: RECRUIT Study
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Cardiac CT, heart disease

Outcome Measures

Primary Outcomes (1)

• Best Practices for CTP

  Collect DICOM cases and determine the best practices for CTP, including radiation dose, image quality and patient comfort

  2 years

Study Arms (1)

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

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MDDX LLC: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

Miami Baptist

Miami, Florida, 33176, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Ricardo Cury, MD

  Miami Baptist

  PRINCIPAL INVESTIGATOR

• James Min, MD

  Cedars Sinai

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2011
• First Posted: May 3, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 11, 2012

Record last verified: 2012-12

Locations

US (1)