NCT00539604

Brief Summary

To determine if 16-64 slice multidetector CT (MDCT) can replace the invasive procedure in patients scheduled for coronary angiography in order to exclude the presence of CAD

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2007

Completed
Last Updated

October 4, 2007

Status Verified

November 1, 2006

First QC Date

October 3, 2007

Last Update Submit

October 3, 2007

Conditions

Coronary Heart Disease

Keywords

Comparison study between MDCT and coronary angiography

Outcome Measures

Primary Outcomes (1)

  • to determine if 16-64 slice multidetector CT (MDCT) can replace the invasive procedure in patients scheduled for coronary angiography in order to exclude the presence of CAD

Secondary Outcomes (2)

  • the efficacy in terms of performance of the MDCT in each single coronary segment and

  • the safety in terms of AE related to both procedures

Interventions

MDCT and Coronary AngiographyPROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients (men or women of any ethnic group) scheduled for a coronary angiography evaluation for a diagnostic work up.
  • Patients will be expected to undergo coronary angiography within 2 weeks after the MDCT study procedure. The coronary angiography must meet the minimum standard laid down in the protocol (see section 8.3.3).
  • Patients must have HDL and total cholesterol performed within the last year.
  • Patients must be willing and able to continue study participation following the reference test to ensure completion of all procedures and observations required by the study.
  • Fully informed and signed consent must be obtained from each patient.

You may not qualify if:

  • Patients under 18 years of age.
  • Patients who have received any investigational drug within the 30 days prior to entering this study.
  • Pregnant or lactating women.
  • Patients who have any contraindication to MDCT examination with iodinate contrast media.
  • Patients with heart rate \>70 bpm despite of β-blocker treatment (see section 8.2.4.1).
  • Patients with no sinus rhythm.
  • Patients with NYHA III or IV class.
  • Patients who have previously undergone CABG or stenting.
  • Patients with a creatinine value \> 2 mg/dl.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Policlinico di Bari Istituto di Radiologia

Bari, Ba, 70124, Italy

Location

Policlinico S. Orsola Malpighi Istituto di Radiologia III

Bologna, Bo, 40138, Italy

Location

Azienda Istituti Ospitalieri U.O. Radiologia

Cremona, CR, 26100, Italy

Location

Istituti clinici Humanitas

Rozzano, Milano, 20089, Italy

Location

Ospedale San Raffaele Istituto di Radiologia

Milan, MI, 20132, Italy

Location

Centro Cardiologico Monzino Servizio di Radiologia

Milan, MI, 20138, Italy

Location

Policlinico di Modena Istituto di Radiologia

Modena, Mo, 41100, Italy

Location

Ospedale G. Pasquinucci Unità Operativa di Radiologia

Massa, Ms, 54100, Italy

Location

Policlinico P. Giaccone Dip. Scienze Radiologiche

Palermo, Pa, 90134, Italy

Location

A.O. Riuniti Unità Operativa di Radiologia

Reggio Calabria, R.C., 89126, Italy

Location

Policlinico Le Scotte DAI dell' Immagine

Siena, SI, 53100, Italy

Location

A.O. S. Maria Dipartimento di Diagnostica per Immagini

Terni, TN, 05100, Italy

Location

Ospedale S. Chiara Dipartimento di Radiologia

Trento, TN, 38100, Italy

Location

Ospedale Molinette Istituto di Radiologia

Torino, To, 10126, Italy

Location

Ospedale S. Maria di Ca' Foncello U.C. Radiologia

Treviso, TV, 31100, Italy

Location

A.O.R.N. Cardarelli Radiologia Generale I Sez.

Napoli, 80131, Italy

Location

Policlinico Tor Vergata Istituto di Radiologia

Roma, 00133, Italy

Location

Policlinico Umberto I Radiologia D.E.A.

Roma, 00161, Italy

Location

Policlinico Umberto I Università degli Studi "La Sapienza" Dip. Scienze Radiologiche

Roma, 00161, Italy

Location

Policlinico Gemelli Istituto di Radiologia

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Alessandro Del Maschio, Med. Doctor

    PRINCIPAL INVESTIGATOR

  • Lorenzo Bonomo, Med. Doctor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2007

First Posted

October 4, 2007

Study Start

July 1, 2004

Study Completion

June 1, 2006

Last Updated

October 4, 2007

Record last verified: 2006-11

Locations

IT(20)