Acute Coronary SyndromeRiskOp-ACSNCT03619395
Risc Optimisation- Acute cor5onary Syndrome
An observational study of Acute Coronary Syndrome and Ischemic Heart Disease, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Ischemic Heart Disease
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 1 Jul 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high cardiovascular risk
Who may be able to join
- patients hospitalized with a diagnosis of acute coronary syndrome who have signed informed consent
Who cannot join
- patients with disability or refusal to sign informed consent or who have comorbidities with a life expectancy of less than 1 year
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Sonia Ruiz Bustillo
Barcelona, 08003
Sonia Ruiz Bustillo, MD, 0034932483118 ext. 3118, sruiz@parcdesalutmar.cat
Consol Ivern Diaz, 0034932483118 ext. 3118, civern@parcdesalutmar.cat
About this study
Official title: Strategies to Optimize the Control of Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
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.
Read the detailed description
Despite the evidence, lipid-lowering pharmacological intervention in secondary prevention remains insufficient. These data are also confirmed in a study conducted in our environment where of a total of 423 high-risk patients only 29% had an optimal control of LDL-C levels and 36% of glycated hemoglobin levels. A possible explanation is the so-called therapeutic inertia defined as the failure of physicians to initiate or intensify an indicated therapy. The inadequate treatment of the risks factors in the high-risk population increases morbidity and mortality, so it is very relevant to find strategies that improve adherence to clinical practice guidelines.
Prospective observational study of a patient population after ACS that will be compared with a historical cohort. All participants will give informed consent before initiating procedures within the cardiac rehabilitation program.
Primary outcome: To analyze the percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended by clinical guidelines following pharmacological optimization protocols based on algorithms developed for this study. These results will be compared with the historical cohort of our hospital (usual practice) Secondary outcome: to analyze if the results of the intensive intervention during the first year are maintained in the long term (5 years)
Baseline clinical, analytical, echocardiographic, coronary anatomy and pharmacological therapy data will be collected. After six weeks of lipid-lowering treatment, a first analytical control will be carried out and, following the specific algorithm designed for this study, oral pharmacological treatment will be adapted if the LDL-C target level is not met. After any change in therapy, a new analytical control will be performed after 8 weeks. Diabetic patients will also undergo a baseline analytical study, if the glycosylated hemoglobin values are not in the range recommended by the clinical practice guidelines, pharmacological treatment optimization will be initiated following the algorithm designed for the study. After three months of treatment, a new control and optimization of the treatment will be carried out according to the protocol designed.
A follow-up will be carried out after 6, 12 months and 5 years
- Conditions
- Acute Coronary Syndrome, Ischemic Heart Disease
- Keywords
- Cardiovascular Secondary prevention, Cardiovascular risk factors control
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated the long term.
LDL cholesterol and glycosylated hemoglobin levels
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Sep 2018
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonia Ruiz Bustillo, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619395
- Sponsor's protocol ID
- ParcSM
- Acronym
- RiskOp-ACS
- Status last verified
- Sep 2019
- First submitted
- 26 Jun 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies to Optimize the Control of Cardiovascular Risk Factors in Patients After an Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03619395
- Acronym / sponsor ID
- RiskOp-ACS / ParcSM
- Conditions
- Acute Coronary Syndrome, Ischemic Heart Disease
- Keywords
- Cardiovascular Secondary prevention, Cardiovascular risk factors control
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite the evidence, lipid-lowering pharmacological intervention in secondary prevention remains insufficient. These data are also confirmed in a study conducted in our environment where of a total of 423 high-risk patients only 29% had an optimal control of LDL-C levels and 36% of glycated hemoglobin levels. A possible explanation is the so-called therapeutic inertia defined as the failure of physicians to initiate or intensify an indicated therapy. The inadequate treatment of the risks factors in the high-risk population increases morbidity and mortality, so it is very relevant to find strategies that improve adherence to clinical practice guidelines.
Prospective observational study of a patient population after ACS that will be compared with a historical cohort. All participants will give informed consent before initiating procedures within the cardiac rehabilitation program.
Primary outcome: To analyze the percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended by clinical guidelines following pharmacological optimization protocols based on algorithms developed for this study. These results will be compared with the historical cohort of our hospital (usual practice) Secondary outcome: to analyze if the results of the intensive intervention during the first year are maintained in the long term (5 years)
Baseline clinical, analytical, echocardiographic, coronary anatomy and pharmacological therapy data will be collected. After six weeks of lipid-lowering treatment, a first analytical control will be carried out and, following the specific algorithm designed for this study, oral pharmacological treatment will be adapted if the LDL-C target level is not met. After any change in therapy, a new analytical control will be performed after 8 weeks. Diabetic patients will also undergo a baseline analytical study, if the glycosylated hemoglobin values are not in the range recommended by the clinical practice guidelines, pharmacological treatment optimization will be initiated following the algorithm designed for the study. After three months of treatment, a new control and optimization of the treatment will be carried out according to the protocol designed.
A follow-up will be carried out after 6, 12 months and 5 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high cardiovascular risk
Key inclusion criteria (1 listed)
- patients hospitalized with a diagnosis of acute coronary syndrome who have signed informed consent
Key exclusion criteria (1 listed)
- patients with disability or refusal to sign informed consent or who have comorbidities with a life expectancy of less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended in the clinical guidelines
Time frame: 12 months
LDL cholesterol and glycosylated hemoglobin levels
1 secondary outcome
Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated the long term.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Ischemic Heart Disease, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients that reach the objective levels of LDL cholesterol and glycosylated hemoglobin recommended in the clinical guidelines (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.