NCT03619395

Brief Summary

This study evaluates the percentage of patients that reach the objective levels of LDL cholesterol, glycosylated hemoglobin and blood pressure recommended by clinical guidelines after an acute coronary syndrome, following strategies of pharmacological optimization based on algorithms. The investigators hypothesize that the use of algorithms designed and protocolized within a cardiac rehabilitation program after an ACS to optimize pharmacological treatment is effective and safe to improve the control of risk factors in patients with high cardiovascular risk.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

June 26, 2018

Last Update Submit

September 4, 2019

Conditions

Acute Coronary SyndromeIschemic Heart Disease

Keywords

Cardiovascular Secondary preventionCardiovascular risk factors control

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended in the clinical guidelines

    LDL cholesterol and glycosylated hemoglobin levels

    12 months

Secondary Outcomes (1)

  • Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated the long term.

    5 years

Eligibility Criteria

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

Patients with high cardiovascular risk

You may qualify if:

  • patients hospitalized with a diagnosis of acute coronary syndrome who have signed informed consent

You may not qualify if:

  • patients with disability or refusal to sign informed consent or who have comorbidities with a life expectancy of less than 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sonia Ruiz Bustillo

Barcelona, 08003, Spain

RECRUITING

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 26, 2018

First Posted

August 7, 2018

Study Start

September 1, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2023

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available within 12 months of study completion
Access Criteria
Requestors will be required to sign a Data Access Agreement

Locations

ES(1)