Pulmonary embolism landmark trials
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Editor(s)-In-Chief: The APEX Trial Investigators, C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-In-Chief: Cafer Zorkun, M.D., Ph.D. [2]
Landmark clinical Trials & Studies
Trials assessing the diagnosis
1. PIOPED (Prospective Investigation in Pulmonary Embolism Diagnosis) (1989).[1]
(ClinicalTrials.gov number, NCT00000566).
- Purpose : To evaluate the sensitivity and specificity of two major, widely used technologies, radionuclear imaging (ventilation-perfusion scanning) and pulmonary angiography, for the diagnosis of pulmonary embolism.
- Study Type: Interventional
- Study Design: Primary Purpose: Diagnostic
2. PIOPED II (Prospective Investigation in Pulmonary Embolism Diagnosis II) (2002).[2]
(ClinicalTrials.gov number, NCT00007085).
- Purpose : It was designed to assess the efficacy of the spiral computed tomographic pulmonary angiogram in patients suspected of having acute pulmonary embolism (PE).
- Study Type: Interventional
- Study Design: Primary Purpose: Diagnostic
- Comparison with PIOPED: In contrast to the original PIOPED study, which used contrast pulmonary angiography as the primary reference test for PE, PIOPED II used composite reference test for venous thromboembolism that was based on the ventilation/perfusion lung scan, venous compression ultrasound of the lower extremities, digital subtraction pulmonary angiography, and contrast venography in various combinations to establish the PE status of the patient. New criteria for ventilation/perfusion lung scan diagnosis were developed for PIOPED II.
3. PIOPED III (Prospective Investigation of Pulmonary Embolism Diagnosis III) (2010). [3]
(ClinicalTrials.gov number, NCT00241826).
- Purpose :The purpose of this study is to determine the diagnostic accuracy of gadolinium-enhanced magnetic resonance angiography (Gd-MRA) of the pulmonary arteries in combination with magnetic resonance venography (MRV) of the veins of the thighs in patients with clinically suspected acute pulmonary embolism (PE).
- Study Type: Observational
- Study Design: Observational Model:Cohort, Time Perspective:Prospective.
Trials assessing the efficacy of LMWH in reducing mortality in acutely ill patients
1. LIFENOX (Study to Evaluate the Mortality Reduction of Enoxaparin in Hospitalized Acutely Ill Medical Receiving Enoxaparin) (2011).[4]
(ClinicalTrials.gov number, NCT00622648).
- Study Type: Interventional
- Study Design: Primary Purpose: Treatment, Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator).
- Conclusion: Enoxaparin plus elastic stockings with graduated compression, failed to show any reduction in the rate of death from any cause among hospitalized, acutely ill medical patients, when compared to elastic stockings with graduated compression alone.
Study assessing the efficacy of Thrombolysis
1. MAPPET (Management Strategy and Prognosis of Pulmonary Embolism Registry) (1997).[5]
Study assessing the factors causing death
1. ICOPER (International Cooperative Pulmonary Embolism Registry) (1999).[6]
Trial evaluating the safety of withholding anticoagulation in subsegmental PE patients
A Multicenter Prospective Cohort Management Study to Evaluate the Safety of Withholding Anticoagulation in Patients With Subsegmental PE Who Have a Negative Serial Bilateral Lower Extremity Ultrasound [3]
(ClinicalTrials.gov number, NCT01455818).
- Purpose: The investigators plan to follow 270 patients with small blood clots in their lungs for 90 days. These patients will not be treated with blood thinners but will be followed closely with other non-invasive tests to avoid progression or recurrence of blood clots.
- Study Type: Observational
- Study Design: Observational Model:Cohort, Time Perspective:Prospective.
References
- ↑ "Value of the ventilation/perfusion scan in acute pulmonary embolism. Results of the prospective investigation of pulmonary embolism diagnosis (PIOPED). The PIOPED Investigators". JAMA. 263 (20): 2753–9. 1990. PMID 2332918.
|access-date=requires|url=(help) - ↑ Gottschalk A, Stein PD, Goodman LR, Sostman HD (2002). "Overview of Prospective Investigation of Pulmonary Embolism Diagnosis II". Semin Nucl Med. 32 (3): 173–82. doi:10.1053/snuc.2002.124177. PMID 12105798. Retrieved 2012-01-10. Unknown parameter
|month=ignored (help) - ↑ Stein PD, Chenevert TL, Fowler SE, Goodman LR, Gottschalk A, Hales CA, Hull RD, Jablonski KA, Leeper KV, Naidich DP, Sak DJ, Sostman HD, Tapson VF, Weg JG, Woodard PK (2010). "Gadolinium-enhanced magnetic resonance angiography for pulmonary embolism: a multicenter prospective study (PIOPED III)". Ann. Intern. Med. 152 (7): 434–43, W142–3. doi:10.1059/0003-4819-152-7-201004060-00008. PMC 3138428. PMID 20368649. Unknown parameter
|month=ignored (help);|access-date=requires|url=(help) - ↑ Kakkar AK, Cimminiello C, Goldhaber SZ, Parakh R, Wang C, Bergmann JF (2011). "Low-molecular-weight heparin and mortality in acutely ill medical patients". N. Engl. J. Med. 365 (26): 2463–72. doi:10.1056/NEJMoa1111288. PMID 22204723. Retrieved 2012-01-13. Unknown parameter
|month=ignored (help) - ↑ Kasper W, Konstantinides S, Geibel A, Olschewski M, Heinrich F, Grosser KD; et al. (1997). "Management strategies and determinants of outcome in acute major pulmonary embolism: results of a multicenter registry". J Am Coll Cardiol. 30 (5): 1165–71. PMID 9350909.
- ↑ Goldhaber SZ, Visani L, De Rosa M (1999). "Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER)". Lancet. 353 (9162): 1386–9. PMID 10227218. Retrieved 2012-01-13. Unknown parameter
|month=ignored (help)