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Evaluation of Secondary Prevention of Cardiac Disease by Nurse Specialists


- candidate number3236
- NTR NumberNTR1290
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-apr-2008
- Secondary IDs06/109 MEC
- Public TitleEvaluation of Secondary Prevention of Cardiac Disease by Nurse Specialists
- Scientific TitleRandomised Evaluation of Secondary Prevention by Outpatient Nurse SpEcialists
- ACRONYMRESPONSE
- hypothesisA 6 month outpatient counselling and treatment course by a nurse (in addition to usual care) reduces the risk of recurrent clinical events compared to usual care alone
- Healt Condition(s) or Problem(s) studiedCardiovascular disease, Acute coronary syndrome (ACS), Prevention, Nurse specialists
- Inclusion criteriaPatients between 18-80 years hospitalised less than 8 weeks before inclusion for an acute coronary syndrome, either unstable angina or acute myocardial infarction, will be included
- Exclusion criteriaPatients will be excluded if clinic visits are not feasible, if not available for follow-up, if surgery, percutaneous coronary intervention or other interventions are expected within 8 weeks, if life expectancy is considered limited, if previously enrolled in NLPC or if NYHA class 3 or 4 from heart failure.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 17-okt-2006
- planned closingdate31-dec-2010
- Target number of participants1000
- InterventionsIntervention group is seen up to 4 times in 6 months following occurrence of acute coronary syndrome at a nurse-led outpatient clinic in addition to usual care. The nurse-led outpatient clinic focuses on lifestyle, established cardiovascular risk factors and medication adherence.
- Primary outcomeCopenhagen Risk score at 12 months follow-up.
- Secondary outcome1. Smoking status
2. Exercise status
3. Body Mass Index
4. Waist-to-hip ratio
5. Blood pressure
-Systolic blood pressure
-Diastolic blood pressure
6. Glucose parameters
-HbA1c
-Fasting glucose
7. Lipid profile
-Total cholesterol
-HDL
-LDL
-Triglycerids
8. Change in Diabetes status

Risk scores:
- Copenhagen Risk score (at 6 months)
- Europa-score26
- PROCAM-score27
- Euroscore28
- SF-36
- MacNew
- TimepointsBaseline
follow-up 6 months
follow-up 12 months
- Trial web sitewww.responsestudie.nl
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD, Research Fellow Harald Thune Jørstad
- CONTACT for SCIENTIFIC QUERIESMD, Research Fellow Harald Thune Jørstad
- Sponsor/Initiator Academic Medical Center (AMC), Department of Cardiology
- Funding
(Source(s) of Monetary or Material Support)
AstraZeneca, Academic Medical Center (AMC), Department of Cardiology
- PublicationsN/A
- Brief summaryRationale: Treatments for secondary prevention of clinical events in patients with coronary artery disease are currently sub-optimally implemented. We hypothesize that a 6 month outpatient counselling and treatment course led by a nurse, in addition to usual care, reduces the risk of recurrent clinical events compared to usual care alone.
Objective:
Primary objective: To quantify the impact of outpatient nurse-led prevention clinics on the risk of future clinical events as calculated by the Copenhagen Risk score in patients with symptomatic coronary artery disease.
Study population: Patients aged 18-80 years who have been hospitalised less than 8 weeks before inclusion for an acute coronary syndrome.
Intervention: Intervention group is seen up to 4 times in 6 months following occurrence of acute coronary syndrome at a nurse-led outpatient clinic in addition to usual. Control group receives usual care only.
Main study parameters: The following parameters (and change herein) are compared at baseline, at 6 months and at 12 months after inclusion in study in both study groups:
1. Copenhagen Risk score
2. Smoking status
3. Exercise status
4. Body Mass Index
5. Waist circumference
6. Systolic blood pressure
7. Diastolic blood pressure
8. Diabetes status, fasting glucose, HbA1c levels
9. Total cholesterol, HDL, LDL, Triglycerides
- Main changes (audit trail)
- RECORD24-apr-2008 - 25-jun-2013


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