Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization (CONSERVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by MDDX LLC
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
MDDX LLC
ClinicalTrials.gov Identifier:
NCT01810198
First received: February 22, 2013
Last updated: September 21, 2013
Last verified: September 2013

February 22, 2013
September 21, 2013
December 2012
February 2018   (final data collection date for primary outcome measure)
MACE Endpoints [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Death
  • Non-fatal myocardial infarction
  • Unstable angina (including new onset angina or those requiring hospitalization, revascularization or that are troponin-positive)
  • Stroke
  • Urgent or emergent coronary revascularization
  • Cardiovascular hospitalization (including for angina, heart failure or other)
Same as current
Complete list of historical versions of study NCT01810198 on ClinicalTrials.gov Archive Site
Additional MACE Endpoints [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • The primary composite MACE endpoint plus major bleeding.
  • The primary composite MACE endpoint plus major bleeding or need for urgent/ emergent surgery due to hemorrhage.
  • The primary composite MACE endpoint plus major bleeding plus need for urgent/ emergent surgery due to hemorrhage plus need for major transfusion.
Same as current
  • Economic [ Time Frame: 4 years ] [ Designated as safety issue: No ]

    The secondary economic endpoint is within-trial cardiovascular costs*.

    *Costs will include index- and downstream CAD-related costs related to diagnostic testing, medications, hospitalizations, emergency department visits, outpatient visits, and coronary revascularizations. (Costs will also include non-CAD-related but test related costs.)

  • Secondary Safety Endpoint [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

    The secondary safety endpoint will be rates of serious test-related complications*.

    *Serious test-related complications will include contrast-induced nephropathy, hematoma requiring transfusion, arteriovenous fistula, aneurysm formation, retroperitoneal bleed, arterial dissection and any surgery for test-related complications and cumulative CAD test-related effective biological radiation dose.

  • Quality of Life [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    The tertiary endpoint will be general and angina-specific quality of life, as measured by the EQ-5D Health Survey and Seattle Angina Questionnaire, respectively.
Same as current
 
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life

To determine the effectiveness, safety, and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association/ American College of Cardiology Class II indication for non-emergent invasive coronary angiography.

A prospective, randomized controlled multicenter trial to determine the clinical and cost effectiveness of a "selective catheterization" strategy versus a "direct catheterization" strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography. Subjects in the "selective catheterization" arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events (MACE) as compare to subjects in the "direct catheterization" strategy.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Coronary Artery Disease
  • Procedure: Cardiac CT
    Perform a non-invasive Cardiac CT Angiogram
  • Procedure: Invasive Coronary Angiography
    Patient undergoes Invasive Coronary Angiography
  • Active Comparator: Cardiac CT
    Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)
    Intervention: Procedure: Cardiac CT
  • Active Comparator: Invasive Coronary Angiography
    Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography
    Intervention: Procedure: Invasive Coronary Angiography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
May 2018
February 2018   (final data collection date for primary outcome measure)

INCLUSION CRITERIA

  1. Age >18 years
  2. Patients providing written informed consent
  3. Scheduled to undergo clinically-indicated non-emergent invasive coronary angiography with an ACC/AHA Class II indication

EXCLUSION CRITERIA

  1. Known CAD (myocardial infarction, PCI, CABG)
  2. ACC/AHA Class I or III indication for ICA
  3. Non-cardiac illness with life expectancy <2 years
  4. Inability to provide written informed consent
  5. Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
  6. Pregnant women
  7. Allergy to iodinated contrast agent
  8. Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate <30 ml/min
  9. Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
  10. Heart rate ≥100 beats per minute

12) Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35

Both
18 Years to 75 Years
No
Contact: Dan Gebow, PhD dgebow@mddx.com
United States,   India,   Italy,   Korea, Republic of
 
NCT01810198
CONSERVE
Yes
MDDX LLC
MDDX LLC
GE Healthcare
Principal Investigator: James Min, MD Cedars Sinai
Study Director: Dan Gebow, PhD MDDX LLC
Principal Investigator: Hyuk-Jae Chang, MD Severance Hospital
MDDX LLC
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP