Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization

Coronary Artery Disease Clinical Trial

— CONSERVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810198
• Other study ID #: CONSERVE
• Status: Completed
• Phase: N/A
• First received: February 22, 2013
• Last updated: March 21, 2017
• Start date: December 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2017
• Source: MDDX LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1631
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß blockers or nitroglycerin 14) Known complex congenital heart disease 15) Body mass index >35

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Cardiac CT
Perform a non-invasive Cardiac CT Angiogram
• Invasive Coronary Angiography
Patient undergoes Invasive Coronary Angiography

Locations

Country	Name	City	State
Brazil	Quanta Diagnostico Nuclear, Curitiba-PR	Curitiba
India	FACTS	Hyderabad
Italy	Centro Cardiologico Monzino	Monzino
Korea, Republic of	Ajou University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Gangneung Asan Hospital	Seoul
Korea, Republic of	Kangwon National University Hospital	Seoul	South Korea
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
Poland	Institute of Cardiology Warsaw	Warsaw
United States	Walter Reed Medical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
MDDX LLC	GE Healthcare

Countries where clinical trial is conducted

United States,  Brazil,  India,  Italy,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Economic	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.)	1 year
Other	Secondary Safety Endpoint	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.	1 year
Other	Quality of Life	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.	1 year
Primary	MACE Endpoints	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)	1 year
Secondary	Additional MACE Endpoints	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.	1 year