NCT02857387

Brief Summary

Atherosclerosis and aging are associated to the raise of biochemical alterations of proteins grouped under the name of " non-enzymatic post-translational modifications ". They often correspond to the irreversible binding of glucose or other oses (glycation) or urea derivatives (carbamylation) on proteins and lead to the formation of complex compounds (post-translational modifications derived products, PTMD) that can accumulate in tissues and be responsible for deleterious effects. The specific role of these compounds in the pathophysiology of aging and atherosclerosis remains unknown, as are the molecular and cellular mechanisms implicated. This project is based on the hypothesis that non-enzymatic post-translational modifications may cause changes in the genesis of complication of coronary atherosclerosis and that PTMD could therefore constitute relevant biomarkers in this specific clinical situation. To explore these potential new biomarkers, the investigators designed a study in patients having experienced an acute coronary syndrome and followed during a year. The concentrations of PTMD assayed at 0, 1, 3, 12 months, will be correlated to clinical (severity and evolution) and paraclinical (cutaneous autofluorescence) data and the effect of cardiac rehabilitation will be assessed. This should help to identify new (and non-traditional) biomarkers of coronary heart disease and determine some of the implicated pathophysiological mechanisms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

October 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

July 29, 2016

Last Update Submit

October 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Post-translational modifications of Proteins quantification assessed by Liquid chromatography-mass spectrometry

    up to 1 year

Study Arms (1)

acute coronary syndrome

EXPERIMENTAL
Biological: blood sample withdrawn

Interventions

acute coronary syndrome

Eligibility Criteria

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

You may qualify if:

  • acute coronary heart syndrome
  • included during hospitalization, usual cardiologic follow-up planned in Reims university hospital

You may not qualify if:

  • \<18yo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

France, Reims, 51092, France

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2016

First Posted

August 5, 2016

Study Start

October 1, 2015

Primary Completion

August 27, 2018

Study Completion

August 27, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations