Pregnancy Related Clinical Trial
Official title:
Study Using OCT_SD to Diagnose Impending Hypertensive Emergency: Relationship to Clinical Findings, Imaging and Outcomes
Verified date | January 2022 |
Source | University of Calgary |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The complications of long-standing severe and acute severe elevations in systemic blood pressure (hypertension) may involve large vessels as well as smaller vessels, these latter comprising what is known as the microcirculation. Diseases of the microcirculation include stroke, dementia, and end stage renal disease to name a few. The microcirculation of the brain (and kidneys) possess a reflex called autoregulation that protects the downstream organ from fluctuations in blood pressure and blood flow. The neurosensory retina of the eye is a forward extension of brain and has a similar microcirculation to that of brain, including the presence of blood retinal barriers and the ability to autoregulate. One of the consequences of very severe hypertension is breakthrough of the autoregulatory reflex with hyperperfusion injury and edema formation. Currently, physicians and scientists have no tools to visualize or measure the human microcirculation or the autoregulatory reflex. SD-OCT is an advanced imaging technology that has a spatial resolution 1000-10,000 times greater than CT or MRI. It is the standard of care for identification and follow-up of structural diseases of the eye. The question this research proposal attempts to answer is whether SD-OCT is able to detect edema or other evidence of structural damage in the eyes in patients in the midst of, or following an episode of very severe hypertension. Pregnant women were chosen to be the focus of this study because: 1) pregnant women are generally young and would be expected to possess a normal microcirculation, 2) the occurrence of new-onset hypertension in pregnancy is high, occurring in 5-10% of all pregnancies, 3) there are established prediction rules that allow one to select and compare women at high- or low-risk of developing hypertension in pregnancy, and finally 4) the spectrum of hypertensive injury in pregnancy ranges from minor elevations in systemic blood pressures to eclampsia, the most severe, life-threatening form of hypertensive injury possible. All this is occurs within a 9-month time window defining human pregnancy. Thus, the investigators are proposing to examine the eyes of women using SD-OCT at low- and high-risk of developing hypertension in pregnancy to determine if, when and how this injury is occurring and its relationship to blood pressures.
Status | Active, not recruiting |
Enrollment | 155 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: Cohort I Women at Low-risk for Developing an HDP (possessing none of the high risk variables outlined in Cohort II below) Cohort II Women at High-risk for Developing an HDP - chronic hypertension - prior preeclampsia - prior gestational hypertension - chronic kidney disease, or - = 2 of the following: age >35 years, body mass index (BMI) > 30 kg/m2, twin or multiple gestation pregnancy, non-Caucasian ethnicity Exclusion Criteria: - pre-existing type 1 or type 2 diabetes mellitus - vasculitis - known or observed retinal disease at enrolment |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Calgary |
Conti E, Zezza L, Ralli E, Caserta D, Musumeci MB, Moscarini M, Autore C, Volpe M. Growth factors in preeclampsia: a vascular disease model. A failed vasodilation and angiogenic challenge from pregnancy onwards? Cytokine Growth Factor Rev. 2013 Oct;24(5):411-25. doi: 10.1016/j.cytogfr.2013.05.008. Epub 2013 Jun 22. Review. — View Citation
Huang J, Liu X, Wu Z, Xiao H, Dustin L, Sadda S. Macular thickness measurements in normal eyes with time-domain and Fourier-domain optical coherence tomography. Retina. 2009 Jul-Aug;29(7):980-7. doi: 10.1097/IAE.0b013e3181a2c1a7. — View Citation
Kanasaki K, Kalluri R. The biology of preeclampsia. Kidney Int. 2009 Oct;76(8):831-7. doi: 10.1038/ki.2009.284. Epub 2009 Aug 5. Review. — View Citation
Magee LA, Pels A, Helewa M, Rey E, von Dadelszen P; Canadian Hypertensive Disorders of Pregnancy Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy: executive summary. J Obstet Gynaecol Can. 2014 May;36(5):416-41. English, French. — View Citation
Wolf M, Shah A, Jimenez-Kimble R, Sauk J, Ecker JL, Thadhani R. Differential risk of hypertensive disorders of pregnancy among Hispanic women. J Am Soc Nephrol. 2004 May;15(5):1330-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Relationship of breach of microcirculatory autoregulatory integrity of the eye, if observed, to breach in other regional circulations | Examples, the kidney where findings of new onset and worsening proteinuria, or elevation of liver enzymes presumably due to gut/visceral edema would be an important outcome of interest in this study. All findings noted and comparisons made, as appropriate. | At < 20 weeks gestation, from 20 weeks gestation up to before delivery, and at delivery | |
Primary | SD-OCT measured change in retinal macular thickness during pregnancy at each gestational period for all study subgroups | The observed change in retinal macular thickness at each gestational period referenced to its baseline measurement in the non-pregnant state will be characterized using both our clinical decision support tool and summary statistics and comparisons made between each subgroup in the study. Some subgroups such as those examining pre-existing and do novo hypertension, or those looking separately at gestational hypertension and preeclampsia may be combined if the pattern of end-tissue response of the retina is the same. | At < 20 weeks gestation, from 20 weeks gestation up to before delivery, and at delivery | |
Secondary | Relationship of mean arterial blood pressure to observed macular response in pregnancy at each gestational interval for all study subgroups | An anticipated relationship between mean arterial blood pressure and macular response (change in macular thickness brought about by hemodynamic factors, including a 1.5-fold increase in cardiac output that is known to peak between 16 and 20 weeks gestation [2], and a 1.3-1.4-fold increase in circulating blood volume peaking in late pregnancy [3]) will be examined by regression analysis. Also, mean arterial pressures will be averaged over each gestational interval for each individual, and summary statistics will be compiled and compared for those in each subgroup. Finally, if hyperperfusion injury is observed to occur in the retina in pregnancy, mean arterial pressure, symptoms/clinical findings, and laboratory abnormalities at the time where macular injury is first detected will be noted and compared for accuracy in defining that event. | At < 20 weeks gestation, from 20 weeks gestation up to before delivery, and at delivery |
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