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Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization (CONSERVE)

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ClinicalTrials.gov Identifier: NCT01810198
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
MDDX LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Cardiac CT Procedure: Invasive Coronary Angiography Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1631 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life
Study Start Date : December 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cardiac CT
Patients who undergo Cardiac CT (instead of Invasive Coronary Angiography)
 Procedure: Cardiac CT
Perform a non-invasive Cardiac CT Angiogram
Active Comparator: Invasive Coronary Angiography
Patients did not undergo Cardiac CT, went straight to Invasive Coronary Angiography
 Procedure: Invasive Coronary Angiography
Patient undergoes Invasive Coronary Angiography


Outcome Measures
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Primary Outcome Measures :
  1. MACE Endpoints [ Time Frame: 1 year ]
    • 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)


Secondary Outcome Measures :
  1. Additional MACE Endpoints [ Time Frame: 1 year ]
    • 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.


Other Outcome Measures:
  1. Economic [ Time Frame: 1 year ]

    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.)


  2. Secondary Safety Endpoint [ Time Frame: 1 year ]

    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.


  3. Quality of Life [ Time Frame: 1 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810198


Locations
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United States, Maryland
Walter Reed Medical Center
Bethesda, Maryland, United States
Brazil
Quanta Diagnostico Nuclear, Curitiba-PR
Curitiba, Brazil
India
FACTS
Hyderabad, India
Italy
Centro Cardiologico Monzino
Monzino, Italy
Korea, Republic of
Kangwon National University Hospital
Seoul, South Korea, Korea, Republic of
Ajou University Hospital
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Gangneung Asan Hospital
Seoul, Korea, Republic of
Korea university, Guro hospital
Seoul, Korea, Republic of
Pusan National University Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Yeongnam University Hospital
Seoul, Korea, Republic of
Poland
Institute of Cardiology Warsaw
Warsaw, Poland
Sponsors and Collaborators
MDDX LLC
GE Healthcare
Investigators
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Principal Investigator: James Min, MD Cornell Weill Medical College
Study Director: Dan Gebow, PhD MDDX LLC
Principal Investigator: Hyuk-Jae Chang, MD Severance Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MDDX LLC
ClinicalTrials.gov Identifier: NCT01810198    
Other Study ID Numbers: CONSERVE
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Keywords provided by MDDX LLC:
Coronary Artery Disease
Cardiac CT
Catheterization
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases