Viability Imaging in Volumetric Angiography (VIVA 1)

MedStar Health

Status: Terminated

Conditions: Myocardial Scarring

Treatments: Other: DE CT

Study type: Interventional

Funder types: Other

Identifiers

NCT01408134

VIVA 1

Details and patient eligibility

About

The primary objective of this study is twofold:

1. To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging
2. To evaluate DE CT image quality using a consensus DECT protocol

Full description

The presence of myocardial scar using radionuclide or magnetic resonance imaging techniques indicates myocardial segments with a reduced likelihood of functional recovery following myocardial revascularization. Preliminary evidence suggests that multi-detector CT (MDCT) angiography also can detect irreversible myocardial scarring through the detection of regions of delayed hyperenhancement (DE) of the myocardium.1-4 However, existing studies have been performed in single centers, and the reproducibility, and impact of this modality on recovery of myocardial function is unknown. In this study, the investigators propose a single-center trial using a standardized MDCT DE protocol among patients scheduled for clinical cardiac CT with planned reoperative surgical. The primary endpoint will be characteristics of DE imaging of the myocardium including its inter-reader variability and factors associated with image quality. These findings will further our understanding of the role of DE MDCT for the detection of myocardial viability.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible patients will be adults, ages 18 and above with:

  1. Known CAD with prior MI based upon clinical history or electrocardiographic criteria
  2. Planned redo-surgical myocardial revascularization
  3. Referred for CT (and eligible) for pre-op substernal mapping/coronary artery evaluation

Exclusion criteria

1. Inability to provide informed consent
2. Allergy to iodinated contrast media (unless pre-medicated with medical prophylaxis)
3. Chronic kidney disease manifested by a serum creatinine >1.5 mg/dL, an estimated creatinine clearance <50 ml/kg/min or on dialysis
4. Currently reporting or evaluated in NYHA class IV heart failure

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)