Acute Coronary Syndrome Clinical Trial
— FLAMEOfficial title:
Randomised Trial of Early Versus Delayed Future Care Planning for Patients and Families Living With Advanced Heart Disease
Verified date | December 2015 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
Patients admitted as an unscheduled hospital admission with either a acute heart failure syndrome (ACF) or acute coronary syndrome (ACS) will be eligible if their 6-12 month mortality risk is estimated to be 20% or greater at the time of discharge. Mortality risk is estimated using GRACE (for ACS) or EFFECT (for AHF) scores. Patients are randomly allocated to receive a holistic care intervention based around the creation of a detailed Future (anticipatory) Care Plan which is agreed with the patient and their family and which is shared with the Family Doctor and Emergency Services including ambulance teams. Primary endpoint is quality of life assessed by questionnaire.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Age > 18 years Unscheduled hospital admission due to congestive heart failure and or acute coronary syndrome 12 month estimated mortality risk of 20% or greater Optimal tolerated medical and device therapy Exclusion Criteria: Expected survival < 28 days Other life limiting non-cardiac condition likely to cause death within 12 months Moderate or severe dementia Moderate or severe cognitive impairment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Scotland |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh |
United Kingdom,
Denvir MA, Highet G, Robertson S, Cudmore S, Reid J, Ness A, Hogg K, Weir C, Murray S, Boyd K. Future Care Planning for patients approaching end-of-life with advanced heart disease: an interview study with patients, carers and healthcare professionals exploring the content, rationale and design of a randomised clinical trial. BMJ Open. 2014 Jul 14;4(7):e005021. doi: 10.1136/bmjopen-2014-005021. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of Life | EuroQoL5D | 6 months | No |
Secondary | Hospital Readmissions | Unscheduled or non-elective admissions to hospital | 6 months | No |
Secondary | Place of Death | Hospital, hospice or home | 6 months | No |
Secondary | DNACPR status documented | Evidence of a discussion and agreed plan for Resuscitation Status of the patient | 6 months | No |
Secondary | Mortality | All cause mortality | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06013813 -
Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT05412927 -
AngelMed Guardian® System PMA Post Approval Study
|
||
Completed |
NCT02750579 -
Early or Delayed Revascularization for Intermediate and High-risk Non ST-elevation Acute Coronary Syndromes?
|
N/A | |
Completed |
NCT04102410 -
Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients
|
N/A | |
Enrolling by invitation |
NCT03342131 -
Serum Concentration of Wnt2 and Wnt4 in Patients With Acute Coronary Syndrome
|
N/A | |
Recruiting |
NCT01218776 -
International Survey of Acute Coronary Syndromes in Transitional Countries
|
||
Enrolling by invitation |
NCT04676100 -
International CR Registry
|
||
Completed |
NCT03590535 -
5th Generation cTnT in ED ACS
|
||
Recruiting |
NCT05437900 -
INSIGHTFUL-FFR Clinical Trial
|
Phase 4 | |
Completed |
NCT05551429 -
Factors Related to Participation in Cardiac Rehabilitation in Patients With Acute Coronary Syndrome
|
||
Terminated |
NCT04316481 -
IDE-ALERTS Continued Access Study
|
N/A | |
Active, not recruiting |
NCT04475380 -
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
|
||
Not yet recruiting |
NCT04852146 -
Electronic Feedback for Data Restitution and Valorization to the Emergency Teams in Aquitaine.
|
||
Active, not recruiting |
NCT02892903 -
In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes?
|
N/A | |
Completed |
NCT02944123 -
Half Dose of Prasugrel and Ticagrelor in Acute Coronary Syndrome (HOPE-TAILOR)
|
Phase 3 | |
Completed |
NCT04077229 -
Piloting Text Messages to Promote Positive Affect and Physical Activity
|
N/A | |
Not yet recruiting |
NCT02871622 -
BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM
|
N/A | |
Active, not recruiting |
NCT02922140 -
The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit
|
N/A | |
Completed |
NCT02673437 -
Rivaroxaban ACS Specialist Cohort Event Monitoring Study
|