NCT01321970

Brief Summary

Our primary goal is to validate a new diagnostic tool for functional coronary artery stenosis that uses multimodal imaging (combining stress echocardiography and stress scintigraphy) in patients with known coronary chest pain.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
2.2 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 19, 2017

Status Verified

March 1, 2015

Enrollment Period

2.5 years

First QC Date

March 23, 2011

Last Update Submit

June 16, 2017

Conditions

Coronary Artery DiseaseCoronary Disease

Outcome Measures

Primary Outcomes (1)

  • The difference between AUCs for multimodal imaging and scintigraphy

    4 days

Secondary Outcomes (1)

  • The difference between AUCs for multimodal imaging and stress ultrasound

    4 days

Study Arms (2)

Severe coronary artery disease

OTHER

Patients in this group have coronary artery disease with a stenosis of \>70%.

Procedure: Stress ultrasoundProcedure: ScintigraphyProcedure: Coronary angiography

Coronary artery disease

OTHER

Patients in this group have coronary artery disease with stenosis \< 70%.

Procedure: Stress ultrasoundProcedure: ScintigraphyProcedure: Coronary angiography

Interventions

Stress ultrasoundPROCEDURE

Qualitative interpretation of the left ventricular wall motion abnormalities is performed in real time in the resting phase and during pharmacological stress. The translation of quantitative data is then performed for each of the 17 segments on a bulls-eye pattern identical to that of scintigraphy.

Coronary artery diseaseSevere coronary artery disease
ScintigraphyPROCEDURE

Image acquisition is synchronized to the electrocardiogram. The tomographic sections are represented in the 3 directions of space, the analysis is also done on the classical representation in 17 segments. (Typically used in ultrasound perfusion scintigraphy or PET).

Coronary artery diseaseSevere coronary artery disease
Coronary angiographyPROCEDURE

Performed in interventional cardiology setting using a guide introduced through the radial or femoral artery. The injection of iodine allows opacification of coronary arteries and their visualization by fluoroscopy. The qualitative interpretation of the data is translated in terms of percentage of stenosis of the coronary artery. It is thus considered that the stenosis is significant at over 70% obstruction of the lumenal diameter. This interpretation is made for each of the three main coronary arteries and their tributaries: * Right coronary (proximal, middle and distal) and collateral (inter ventricular posterior ventricular posterior retro) * Inter ventricular anterior (proximal, middle and distal) and its tributaries (diagonal and septal) * Circumflex (proximal, middle and distal) and collateral (first and second marginal)

Coronary artery diseaseSevere coronary artery disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient has a documented coronaropathy
  • The patient needs a new coronarography following symptoms indicating a change in his/her coronary disease state

You may not qualify if:

  • The patient is participating in another study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant
  • The patient is breastfeeding
  • Patients with arrhythmias, left bundle branch block on the electrocardiogram which would complicate the interpretation of examinations
  • Unstable, acute coronary syndromes unstable needing emergency coronary angiography
  • Patient with contraindication for conducting a stress test:
  • poorly controlled hypertension
  • pre-existing severe arrhythmia
  • aortic stenosis
  • and obstructive hypertrophic cardiomyopathy
  • Patient has contraindication for atropine
  • History of prostate adenoma
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Madeleine Rubini, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 19, 2017

Record last verified: 2015-03

Locations

FR(1)