Skip to main content
OpenTrials
Completed

NCT Number: NCT01810198

Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Quanta Diagnostico Nuclear, Curitiba-PR, Curitiba, Brazil

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Known CAD (myocardial infarction, PCI, CABG)
  • ACC/AHA Class I or III indication for ICA
  • Non-cardiac illness with life expectancy <2 years
  • Inability to provide written informed consent
  • Concomitant participation in another clinical trial in which subject is subject to investigational drug or device
  • Pregnant women
  • Allergy to iodinated contrast agent
  • Serum creatinine ≥1.5 mg/dl or Glomerular Filtration Rate <30 ml/min
  • Uncontrolled Baseline irregular heart rhythm (e.g., atrial fibrillation, etc.)
  • Heart rate ≥100 beats per minute
  • Systolic blood pressure ≤90 mm Hg 13) Contraindications to β blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35

Treatment and study plan

Cardiac CT

Procedure

Perform a non-invasive Cardiac CT Angiogram

invasive coronary angiography

Procedure

Patient undergoes Invasive Coronary Angiography

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

MDDX LLC

Industry

Collaborators

  • GE Healthcare

Registry information

Official study title

Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization: Relation to CardioVascular Outcomes, Cost Effectiveness and Quality of Life

Acronym: CONSERVE

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 13, 2013
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.