NCT03479580

Brief Summary

Long-term prognostic value of macrovascular and microvascular coronary artery stenoses in each type of cardiomyopathy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress83%
Feb 2018Feb 2028

First Submitted

Initial submission to the registry

January 23, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

February 8, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

10 years

First QC Date

January 23, 2018

Last Update Submit

May 18, 2022

Conditions

HypertrophicIschemicRestrictive CardiomyopathyDilated Cardiomyopathies

Keywords

CardiomyopathyMultimodal imagingCoronary artery diseaseCoronary microvascular diseasePrognosisAtherosclerosisMyocardial ischemia

Outcome Measures

Primary Outcomes (1)

  • Major Adverse Cardiovascular Events

    Composite outcome = rate of cardiovascular death, non-fatal myocardial infarction, need for myocardial revascularization by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) \> 3 months after enrollment. During follow up

    5 years

Interventions

Patients with a cardiomyopathyOTHER

Prognostic value of coronary artery disease and microvascular disease in the different types of cardiomyopathies.

Eligibility Criteria

Age18 Years - 100 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale and Male
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with a cardiomyopathy

You may qualify if:

  • Ischemic
  • Dilated
  • Hypertrophic
  • Restrictive cardiomyopathy.

You may not qualify if:

  • Pregnant women
  • Breastfeeding women
  • Patients under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

La Tronche, 38700, France

RECRUITING

MeSH Terms

Conditions

HypertrophyIschemiaCardiomyopathy, RestrictiveCardiomyopathy, DilatedCardiomyopathiesCoronary Artery DiseaseMicrovascular AnginaAtherosclerosisMyocardial Ischemia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic ProcessesHeart DiseasesCardiovascular DiseasesCardiomegalyLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCoronary DiseaseArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAngina Pectoris

Study Officials

  • Gilles BARONE-ROCHETTE, PI

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clémence CHARLON

CONTACT

0033476766652ccharlon@chu-grenoble.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2018

First Posted

March 27, 2018

Study Start

February 8, 2018

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations

FR(1)