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
  Purpose

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 Intervention
Coronary Artery Disease
Procedure: Cardiac CT
Procedure: Invasive Coronary Angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Further study details as provided by MDDX LLC:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 1500
Study Start Date: December 2012
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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: NCT01810198

Contacts
Contact: Dan Gebow, PhD dgebow@mddx.com

Locations
United States, Maryland
Walter Reed Medical Center Not yet recruiting
Bethesda, Maryland, United States
Contact: Todd Villines, MD         
Principal Investigator: Todd Villines, MD         
India
FACTS Recruiting
Hyderabad, India
Contact: Ravi Bathina, MD       ravibathina@yahoo.com   
Principal Investigator: Ravi Bathina, MD         
Italy
Centro Cardiologico Monzino Recruiting
Monzino, Italy
Contact: Gianluca Pontone, MD         
Principal Investigator: Daniele Andreini         
Korea, Republic of
Kangwon National University Hospital Recruiting
Seoul, South Korea, Korea, Republic of
Contact: HER AE-YOUNG, MD    82-10-6375-3863      
Principal Investigator: HER AE-YOUNG, MD         
Gangneung Asan Hospital Recruiting
Seoul, Korea, Republic of
Contact: Shin Dae-Hee, MD    82-10-9986-1291      
Principal Investigator: Shin Dae-Hee, MD         
Yeongnam University Hospital Recruiting
Seoul, Korea, Republic of
Contact: KIM WOONG, MD    82-10-4504-1507      
Principal Investigator: KIM WOONG, MD         
Korea university, Guro hospital Recruiting
Seoul, Korea, Republic of
Contact: KIM JIN-WON, MD    82-10-6380-3006      
Principal Investigator: Kim JIN-WON, MD         
Pusan National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Choi Junghyun, MD    82-10-7133-3594      
Principal Investigator: Choi Junghyun, MD         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: HYUK-JAE CHANG, MD    82-2-2228-8460      
Principal Investigator: HYUK-JAE CHANG, MD         
Ajou University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Choi So-Yeon, MD    82-10-8632-5690      
Principal Investigator: Choi So-Yeon, MD         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: CHOI EUI-YOUNG, MD    82-10-2521-8022      
Principal Investigator: CHOI EUI-YOUNG, MD         
Sponsors and Collaborators
MDDX LLC
GE Healthcare
Investigators
Principal Investigator: James Min, MD Cedars Sinai
Study Director: Dan Gebow, PhD MDDX LLC
Principal Investigator: Hyuk-Jae Chang, MD Severance Hospital
  More Information

No publications provided

Responsible Party: MDDX LLC
ClinicalTrials.gov Identifier: NCT01810198     History of Changes
Other Study ID Numbers: CONSERVE
Study First Received: February 22, 2013
Last Updated: September 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by MDDX LLC:
Coronary Artery Disease
Cardiac CT
Catheterization

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

ClinicalTrials.gov processed this record on October 21, 2014