The Anticoagulation of Calf Thrombosis (ACT) project: study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Half of all lower limb deep vein thrombi (DVT) in symptomatic ambulatory patients are located in the distal (calf) veins. While proximal disease warrants therapeutic anticoagulation to reduce the associated risks, distal DVT often goes untreated. However, a proportion of untreated distal disease will undoubtedly propagate or embolize. Concern also exists that untreated disease could lead to long-term post thrombotic changes. Currently, it is not possible to predict which distal thrombi will develop such complications. Whether these potential risks outweigh those associated with unrestricted anticoagulation remains unclear. The Anticoagulation of Calf Thrombosis (ACT) trial aims to compare therapeutic anticoagulation against conservative management for patients with acute symptomatic distal deep vein thrombosis.</p> <p>Methods</p> <p>ACT is a pragmatic, open-label, randomized controlled trial. Adult patients diagnosed with acute distal DVT will be allocated to either therapeutic anticoagulation or conservative management. All patients will undergo 3 months of clinical and assessor blinded sonographic follow-up, followed by 2-year final review. The project will commence initially as an external pilot study, recruiting over a 16-month period at a single center to assess feasibility measures and clinical event rates. Primary outcome measures will assess feasibility endpoints. Secondary clinical outcomes will be collected to gather accurate data for the design of a definitive clinical trial and will include: (1) a composite endpoint combining thrombus propagation to the popliteal vein or above, development of symptomatic pulmonary embolism or sudden death attributable to venous thromboembolic disease; (2) the incidence of major and minor bleeding episodes; (3) the incidence of post-thrombotic leg syndrome at 2 years using a validated screening tool; and (4) the incidence of venous thromboembolism (VTE) recurrence at 2 years.</p> <p>Discussion</p> <p>The ACT trial will explore the feasibility of comparing therapeutic anticoagulation to conservative management in acute distal DVT, within a modern cohort. We also aim to provide contemporary data on clot propagation, bleeding rates and long-term outcomes within both groups. These results will inform the conduct of a definitive study if feasibility is established.</p> <p>Trial registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRCTN75175695">ISRCTN75175695</a></p

Vectorcardiogram more sensitive than 12‐lead ECG in the detection of inferior myocardial infarction

Summary. The vectorcardiogram (VCG) is commonly stated to be more sensitive than the 12‐lead electrocardiogram (ECG) for the diagnosis of inferior myocardial infarction. However, a recent study indicated that VCG is not superior to ECG for this diagnosis. The purpose of this study was to compare the performance of VCG and ECG criteria and to indicate possible explanations for the disagreement between earlier studies. Accordingly, we studied 65 patients with inferior myocardial infarction verified by left ventriculography or 201‐TI myocardial scintigraphy and 351 normal subjects. Sensitivity was 69% (45/65) and 43% (28/65) for the VCG and ECG criteria, respectively. This difference was highly significant (P<0·001). Among the normal subjects there were only three with false positive VCG and none with false positive ECG. We conclude that both VCG and ECG criteria for the diagnosis of inferior myocardial infarction are highly specific and that VCG criteria have greater sensitivity than ECG criteria

Measurement of pulmonary density by means of X-ray computerized tomography. Relation to pulmonary mechanics in normal subjects

We examined the relationship between pulmonary density, measured with computerized tomography, and pulmonary mechanics (static pulmonary volume; pulmonary resistance) in 39 normal subjects (20 nonsmokers and 19 smokers). Pulmonary density decreased with increasing static elastic recoil pressure, and smokers consistently showed higher pulmonary density than nonsmokers. Pulmonary density, measured at full inspiration, correlated inversely with total lung capacity. Pulmonary density showed a ventrodorsal gradient, which was greater at low elastic recoil pressure than at high recoil pressure. The study shows that pulmonary density is related to the mechanical properties of the lung in normal subjects. Increased pulmonary density appears to be a sensitive indicator of pulmonary damage induced by smoking. Further studies of the relationship between pulmonary density and pulmonary mechanics in disease seem warranted