Prospective MRI evaluation of cardiac function in pregnancy

Study ID
STU 042012-014

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Lisa Moseley
214-648-2591
lisa.moseley@utsouthwestern.edu

Principal Investigator
Robert Stewart

Summary

This will be a prospective observational study of pregnant women who present for prenatal care at The university of Texas Southwestern Medical Center and Parkland Health and Hospital System. all information will be obtained and stored in a newly formed centralized electronic database. That information will be deidentified prior to storage, and kept on an encrypted, password protected computer.
Two cohorts of patients will be identified at their initial first trimester prenatal visit. The first cohort will consist of ten healthy, nulliparous women without known medical complications with a BMi between 18.5 and 30. The second cohort will consist of ten obese nulliparous women (BMi 30-35) without known medical disease. Women who are found to qualify will be approached at their first prenatal visit, and informed consent obtained. Women will undergo cardiac MRi at five scheduled intervals throughout pregnancy and the post-partum. The cardiac MRis will be performed at gestational ages of 10 to 16 weeks completed gestation, 26 to 30 weeks completed gestation, and 32 to 40 weeks completed gestation. Cardiac MRi will also be performed within 1 week after delivery as well as 3 months post-partum. The MRis performed will not include the use of gadolinium and will be performed on the 1.5 Tesla magnet. all cardiac MRi's will be interpreted by a single investigator. Data to be collected includes structural measurements of cardiac mass and structure. Functional data will be obtained regarding ventricular function, ventricular volume, and diastolic function.
another cohort of nulliparous, non-obese, healthy women without known medical disease diagnosed with severe pre-eclampsia will be obtained at the time of their delivery. We will identify 10 patients with severe pre-eclampsia. Pre-eclampsia is defined as a new onset of hypertension of [Greater Than]140mmHg systolic or [Greater Than]90 mmHg diastolic with proteinuria ([Greater Than]300mg in a 24 hour urine collection). The diagnosis of severe pre-eclampsia includes new onset hypertension of [Greater Than]160mmHg systolic or [Greater Than]110mmHg diastolic with proteinuria. Women can also be diagnosed with severe pre-eclampsia if they have a blood pressures [Greater Than]140/90 and have one of the following: proteinuria of 2+ on a catheter collected dipstick urine sample or [Greater Than]2 grams protein on a 24 hour urine collection, new onset neurological symptoms of headache or scotomata, midepigastric pain, or laboratory abnormalities of aST greater than 2 times laboratory defined normal, platelets less than 100, or creatanine greater than 1.0. Women who meet these inclusion criteria will be approached for enrollment in the study. Those who agree to participate will receive a cardiac MRi within 1 week of delivery and at 3 months post-partum, with data points being collected the same as previously defined.
each of the subjects will have blood drawn (10 ml) via venipuncture, and blood will be sent for the following lab tests: nT-proBnP, troponin T and i, BMP. Blood samples will be obtained at the following times during the study: 1) upon initial enrollment (at first prenatal visit), 2) on presentation to Labor and Delivery at the time of delivery 3) 3 months post-partum. The subjects in preeclampsia group will have blood drawn at times of MRis as described above.
Compensation will be provided to the women who agree to participate. in the cohort of normal pregnancies, the women will receive $50 for the MRi at 10-16 weeks, $50 at 26-30 weeks, $100 at 32-40 weeks, $100 within 1 week of delivery, and $300 at the final MRi performed at 3 months post-partum, for a total of $600 compensation for the study. The women who are severe preeclamptics and recruited while on labor and delivery will receive $100 for the first MRi performed within 1 week post-partum, and $200 for the final MRi completed at 3 months post-partum, for a total of $300.
a MRi Test Scan Sub-Study of a single test case study will be performed by the investigative team prior to the initiation of the study.

Participant Eligibility

Inclusion criteria will include:
1. maternal age 18-30 years
2. nulliparity
3. BMI within one of two cohorts, 18.5-30 or 30-35.
Inclusion in the third cohort will consist of:
1. maternal age 18-30 years old
2. primigravid
3. diagnosis of severe pre-eclampsia.