NCT02484144

Brief Summary

French study, multicentrique with the cooperation of several hospital centers . 700 patients (200 in the stage 1 and 500 in the stage 2). Every patient will complete questionnaires in a anonymous way.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
821

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

40 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

First Submitted

Initial submission to the registry

June 24, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

June 24, 2015

Last Update Submit

October 13, 2016

Conditions

Keywords

informationcoronarographyunderstanding

Outcome Measures

Primary Outcomes (1)

  • Improvement of the quality of the information of the patients

    Improvement of the quality of the information of the patients by a video about the coronarography (realization of the procedure, the profits and the risks) associated with a written information. The quality of the information will be estimated by a dedicated score.

    one day

Study Arms (2)

patients receive usual information

Patients receive usual information before Scheduled Coronarography

Other: usual information

patients receive modern information

Patients receive usual information and a information by video before Scheduled Coronarography

Other: modern informationOther: usual information

Interventions

information by video for coronarography

patients receive modern information

usual information for coronarography

patients receive modern informationpatients receive usual information

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with scheduled coronarography

You may qualify if:

  • hospitalisation for scheduled coronarography

You may not qualify if:

  • Coronarographies with general anesthesia.
  • Patients not speaking or not reading French, or having linguistic knowledge not allowing the delivery of an appropriate information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

CHU Amiens

Amiens, France

Location

CHU Jean MINJOZ

Besançon, 25030, France

Location

Chu Avicennes

Bobigny, France

Location

Chu Brest

Brest, France

Location

Hôpital Cardiologique Louis Pradel

Bron, France

Location

Ch Chartres

Chartres, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, France

Location

Chu Mondor

Crétail, France

Location

CHU Dijon

Dijon, France

Location

Chu Grenoble

Grenoble, France

Location

CH Lagny

Jossigny, France

Location

CH MANS

Le Mans, France

Location

Chru Lille

Lille, France

Location

Chu Marseille

Marseille, France

Location

CH

Mâcon, France

Location

CH d'ANNECY-GENEVOIS

Metz-Tessy, France

Location

Groupe intercommunal Le Raincy Montfermeil

Montfermeil, France

Location

CHRU

Montpellier, France

Location

CHI André Grégoire

Montreuil, France

Location

CHU Nord LAENNEC

Nantes, France

Location

Clinique Ambroise Paré

Neuilly-sur-Seine, France

Location

Chu Nimes

Nîmes, France

Location

Chu Pitie Salpetriere

Paris, 75013, France

Location

European Georges Pompidou Hospital

Paris, 75015, France

Location

Bichat

Paris, France

Location

Chu Ambroise Paré

Paris, France

Location

CHU Saint Antoine

Paris, France

Location

Cochin

Paris, France

Location

Lariboisière

Paris, France

Location

Ch Perpignan

Perpignan, France

Location

Hopital Cardiologique Haut Lévèque

Pessac, France

Location

CHU Poitiers

Poitiers, France

Location

Chu Reims

Reims, France

Location

Chu Rennes

Rennes, 35000, France

Location

CH Yves Le FOLL

Saint-Brieuc, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93200, France

Location

Chu Strasbourg

Strasbourg, France

Location

CHU Toulouse Rangueil

Toulouse, 31059, France

Location

Hôpital Trousseau

Tours, France

Location

CHRU Nancy

Vandœuvre-lès-Nancy, France

Location

Related Publications (1)

  • Lattuca B, Barber-Chamoux N, Alos B, Sfaxi A, Mulliez A, Miton N, Levasseur T, Servoz C, Derimay F, Hachet O, Motreff P, Metz D, Lairez O, Mewton N, Belle L, Akodad M, Mathivet T, Ecarnot F, Pollet J, Danchin N, Steg PG, Juilliere Y, Bouleti C; INFOCORO investigators. Impact of video on the understanding and satisfaction of patients receiving informed consent before elective inpatient coronary angiography: A randomized trial. Am Heart J. 2018 Jun;200:67-74. doi: 10.1016/j.ahj.2018.03.006. Epub 2018 Mar 12.

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2015

First Posted

June 29, 2015

Study Start

July 1, 2015

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations