Abstract:
BACKGROUND:The management of patients with angiographically intermediate coronary lesions is a major clinical issue. Fractional flow reserve provides validated functional insights while optical coherence tomography provides high resolution anatomic imaging. Both techniques may be applied to guide management in case of angiographically intermediate coronary lesions. Moreover, these techniques may be used to optimize the result of percutaneous coronary intervention. We aim to compare the clinical and economic impact of fractional flow reserve versus optical coherence tomography guidance in patients with angiographically intermediate coronary lesions. METHODS/DESIGN:Patients with at least one angiographically intermediate coronary lesion will be randomized (ratio 1:1) to fractional flow reserve or optical coherence tomography guidance. In the fractional flow reserve arm, percutaneous coronary intervention will be performed if fractional flow reserve value is ≤0.80, and will be conducted with the aim of achieving a post-percutaneous coronary intervention fractional flow reserve target value of ≥0.90. In the optical coherence tomography arm, percutaneous coronary intervention will be performed if percentage of area stenosis (AS%) is ≥75% or 50 to 75% with minimal lumen area <2.5 mm2, or if a major plaque ulceration is detected. In case of percutaneous coronary intervention, optical coherence tomography will guide the procedure in order to minimize under-expansion, malapposition, and edge dissections.Cost load and clinical outcome will be prospectively assessed at one and thirteen months. The assessed clinical outcome measures will be: major cardiovascular events and occurrence of significant angina defined as a Seattle Angina Questionnaire score <90 in the angina frequency scale. DISCUSSION:The FORZA trial will provide useful guidance for the management of patients with coronary artery disease by prospectively assessing the use of two techniques representing the gold standard for functional and anatomical definition of coronary plaques. TRIAL REGISTRATION:Clinicaltrials.gov NCT01824030.
journal_name
Trialsjournal_title
Trialsauthors
Burzotta F,Leone AM,De Maria GL,Niccoli G,Coluccia V,Pirozzolo G,Saffioti S,Aurigemma C,Trani C,Crea Fdoi
10.1186/1745-6215-15-140subject
Has Abstractpub_date
2014-04-23 00:00:00pages
140issn
1745-6215pii
1745-6215-15-140journal_volume
15pub_type
杂志文章,随机对照试验相关文献
Trials文献大全abstract:BACKGROUND:Obesity represents a major public health problem and is the fifth leading risk factor for mortality. Morbid obesity is associated with chronic systemic inflammation which increases the risk of comorbidities. Bariatric surgery (BS) is considered an effective intervention for obese patients. However, BS is ass...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2844-8
更新日期:2018-10-31 00:00:00
abstract:BACKGROUND:Incurable cancer does not only affect patients, it also affects the lives of their partners. Many partners take on caregiving responsibilities. The burden of these caregiving tasks are often associated with physical, psychological, and social difficulties and many partners have unmet supportive care needs. O...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-4037-5
更新日期:2020-01-31 00:00:00
abstract:BACKGROUND:Sub-threshold depression is common, impairs functioning, and increases the risk of developing major depression. Although psychological treatments have been investigated for sub-threshold depression, they are costly. A less costly alternative could be an educational health promotion campaign about effective s...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-11
更新日期:2011-01-13 00:00:00
abstract:BACKGROUND:Whiplash-associated disorders (WAD) are an enormous and costly burden to Australian society. Up to 50% of people who experience a whiplash injury will never fully recover. Whiplash is resistant to treatment and no early management approach has yet been shown to prevent chronic pain. The early presence of cen...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2450-9
更新日期:2018-01-17 00:00:00
abstract:BACKGROUND:Nitrogen containing bisphosphonates such as zoledronic acid (ZA) are known to contain certain anti-cancer properties. These have been investigated in the past in various cancers such as breast, prostate and colon. ZA in particular has shown promising results in pre-clinical studies. We propose a multicentre ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2851-9
更新日期:2018-08-29 00:00:00
abstract:BACKGROUND:The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1405-2
更新日期:2016-06-02 00:00:00
abstract:BACKGROUND:Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibi...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-141
更新日期:2014-04-24 00:00:00
abstract:BACKGROUND:Incomplete recovery from facial palsy results in social and physical disabilities, and the medical options for the sequelae of Bell's palsy are limited. Acupuncture is widely used for Bell's palsy patients in East Asia, but its efficacy is unclear. METHODS:We performed a randomized controlled trial includin...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0777-z
更新日期:2015-06-03 00:00:00
abstract:BACKGROUND:Spleen qi deficiency (SQD), a syndrome based on traditional Chinese medicine (TCM) theory, is common in patients after radical gastrectomy. SQD manifests with chronic gastrointestinal disorders and systemic symptoms and is challenging to manage. Hou Gu Mi Xi (HGMX) is a dietary TCM formula for SQD. This stud...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3429-x
更新日期:2019-06-10 00:00:00
abstract:BACKGROUND:Colonoscopy is one of the most effective methods of cancer prevention and detection, particularly for individuals with familial risk. Recruitment of family members to behavioral intervention trials remains uniquely challenging, owing to the intensive process required to identify and contact them. Recruiting ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-116
更新日期:2013-04-30 00:00:00
abstract:BACKGROUND:The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, in patients who have responded to 16-18 weeks first-line chemotherapy in metastatic colorectal cancer (mCRC). METHODS:The study design is a pr...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-4194-6
更新日期:2020-03-06 00:00:00
abstract:BACKGROUND:Contrast-induced nephropathy (CIN) is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, ...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-11-122
更新日期:2010-12-20 00:00:00
abstract:BACKGROUND:Anxiety in children is common and incapacitating and increases the risk of mental health disorders in adulthood. Although effective interventions are available, few children are identified and referred for specialist treatment. Alternative approaches in which prevention programmes are delivered in school app...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-77
更新日期:2014-03-13 00:00:00
abstract:BACKGROUND:The role of antibiotics in surgical procedures where the risk of surgical site infection (SSI) is low remains uncertain. There is, to date, no evidence to justify the routine use of antibiotics in postoperative reduction mammaplasty. The aim of this study is to evaluate the effect of postoperative antibiotic...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1700-y
更新日期:2016-11-30 00:00:00
abstract:BACKGROUND:Previous interventions to increase physical activity and reduce cardiovascular risk factors have been targeted at individuals with established disease; less attention has been given to intervention among individuals with high risk for disease nor has there been determination of the influence of setting in wh...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-12-45
更新日期:2011-02-16 00:00:00
abstract:BACKGROUND:Fibroblast growth factor 23 (FGF23) is associated with left ventricular hypertrophy (LVH) in patients with chronic kidney disease, and calcimimetic therapy reduces plasma concentrations of FGF23. It remains unknown whether treatment with the calcimimetic etelcalcetide (ETL) reduces LVH in patients on hemodia...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3707-7
更新日期:2019-10-24 00:00:00
abstract:BACKGROUND:Liver failure patients have traditionally been empirically transfused prior to invasive procedures. Blood transfusion is associated with immunologic and nonimmunologic reactions, increased risk of adverse outcomes and high costs. Scientific evidence supporting empirical transfusion is lacking, and the best a...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-1835-5
更新日期:2017-02-27 00:00:00
abstract:BACKGROUND:More than 60,000 people have health problems due to chemical weapons exposure during the Iran-Iraq war. Respiratory consequences of mustard gas exposure are common and disabling; medical interventions have limited effect. Patients complain of cough, sputum, breathlessness and exercise limitation. We hypothes...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3180-3
更新日期:2019-02-14 00:00:00
abstract:BACKGROUND:The focus in recent years on physical inactivity and metabolic disturbances in individuals with schizophrenia raises the question of potential effects of physical activity. Physical activity has shown beneficial effects on cognition in healthy older individuals as well as on symptom severity in depression. H...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-1094-2
更新日期:2015-12-08 00:00:00
abstract:BACKGROUND:Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia. Combination immunochemotherapy such as fludarabine, cyclophosphamide and rituximab is the standard first line therapy in fit patients, but there is limited evidence regarding the optimal treatment of patients after relapse. Ofatumumab as...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1581-0
更新日期:2016-09-20 00:00:00
abstract::Following the South African case, Treatment Action Campaign and Others v Minister of Health and Others, the use of 'pilot' studies to investigate interventions already proven efficacious, offered free of charge to government, but confined by the government to a small part of the population, may violate children's righ...
journal_title:Trials
pub_type: 杂志文章,评审
doi:10.1186/1745-6215-15-287
更新日期:2014-07-16 00:00:00
abstract:BACKGROUND:In the presence of heterogeneous treatment effects, it is desirable to divide patients into subgroups based on their expected response to treatment. This is formalised via a personalised treatment recommendation: an algorithm that uses biomarker measurements to select treatments. It could be that multiple, r...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04901-2
更新日期:2021-01-06 00:00:00
abstract:BACKGROUND:Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0635-z
更新日期:2015-04-02 00:00:00
abstract:BACKGROUND:There is no existing report on the quality of randomized controlled trials (RCTs) of melasma treatment currently conducted in China. This study aims to assess the quality of RCT- reporting in the treatment of melasma conducted in China. METHODS:Several databases were searched from their inception through to...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-015-0677-2
更新日期:2015-04-12 00:00:00
abstract:BACKGROUND:Assistive technology and telecare (ATT) are relatively new ways of delivering care and support to people with social care needs. It is claimed that ATT reduces the need for community care, prevents unnecessary hospital admission, and delays or prevents admission into residential or nursing care. The current ...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-349
更新日期:2013-10-23 00:00:00
abstract:BACKGROUND:It is expected that in 2020 more than 17,000 cases of colorectal cancer will be diagnosed in The Netherlands. To date, patients are included in a surgeon-led follow-up programme whose main focus is recurrence detection. However, patients often experience multiple physical and psychosocial problems. Currently...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-015-0798-7
更新日期:2015-06-26 00:00:00
abstract:BACKGROUND:Frozen shoulder (FS) is a musculoskeletal condition of poorly understood etiology that results in shoulder pain and large mobility deficits. Despite some physical therapy interventions, such as joint mobilization and exercise, having shown therapeutic benefit, a definitive treatment does not currently exist....
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3585-z
更新日期:2019-08-13 00:00:00
abstract:BACKGROUND:Surgical site infections (SSI) remain one of the most common complications in conventional abdominal surgery with an incidence between 4% and 19% (Sandini et al., Medicine (Baltimore) 95:e4057, 2016) in the literature. It is unclear whether the use of coated suture material for skin closure reduces the risk ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-019-3492-3
更新日期:2019-07-02 00:00:00
abstract:BACKGROUND:Age-related muscle wasting has been strongly implicated with falls and fractures in the elderly, but it has also been associated with cognitive decline and dementia. Progressive resistance training (PRT) and adequate dietary protein are recognised as important contributors to the maintenance of muscle health...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0884-x
更新日期:2015-08-08 00:00:00
abstract:BACKGROUND:Chronic thoracic pain after cardiac surgery is prevalent (11 to 56%) and may affect patients' physical and mental health status. Despite its favorable pharmacokinetic and pharmacodynamic properties, high doses of remifentanil administered during surgery are reported to cause acute postoperative pain and incr...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-466
更新日期:2014-11-27 00:00:00