Women's Ischemia Syndrome Evaluation (WISE) Pre-HFpEF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
The purpose of this study is to examine small vessel disease (a condition in which the small arteries in the heart become narrowed). The investigators want to know how the small vessel disease contributes to pre-HFpEF (a condition with inadequate heart muscle function in the setting of preserved muscle pumping) and to better identify potential treatment for prevention of HFpEF. The main procedures of this study include up to 2 clinic visits (initial visit and a second clinical visit only if participants are unable to complete all research procedures at the initial visit); a 6-week phone interview visit, 4 quarterly follow-up phone interview visits in year 1; year 1 follow up cardiac MRI based on availability and ongoing annual follow-up phone interview visits to track progress. If participants choose to take part in this study, participants direct participation will end after 1 year, participants will then have the option of participating in ongoing annual check-in calls. Participants will be asked to undergo a physical exam and provide a completed medical history; complete a Cardiovascular (or Cardiac) Magnetic Resonance Imaging (CMRI) with contrast agent; complete questionnaires to describe heart symptoms and overall quality of life status; undergo blood draws to provide blood samples for research testing, and allow the study team to have access to medical records.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
180 symptomatic men and women undergoing invasive coronary angiography for suspected ischemia with no obstructive CAD, defined as ≥50% luminal diameter stenosis in ≥1 epicardial coronary artery.
Preserved left ventricular ejection fraction (EF) ≥45%
Be > 18 years old
Be able to meet the requirement for a cardiac MRI, which means no metal devices in your chest, no claustrophobia and no angioedema
Disqualifiers
None
Trial population
Men and women undergoing invasive coronary angiography for suspected ischemia with no obstructive CAD, defined as ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
CMR imaging
Change from Baseline at 1 year follow up will be assessed.
Time frame
Baseline, Annual follow up2
Rest-stress Millar pressure-volume measurement
LV diastolic function will be measured using LV end-diastolic pressure, minimal rate of LV pressure change (dP/dtmin).
Time frame
BaselineSecondary outcomes
1
Questionnaire
Symptom History Questionnaire. Change from Baseline at each visit will be measure. There is no scale ranges for this questionnaire. This questionnaire results in raw data that is not calculated into a score or scale.
Time frame
Baseline, 6 week, quarterly(year 1) and annual follow up2
Questionnaire WISE Symptoms History
Detailed information on chest pain symptoms will include the WISE female angina questionnaire. Change from Baseline at each visit will be measure. There is no scale ranges for this questionnaire. This questionnaire results in raw data that is not calculated into a score or scale.
Time frame
Baseline, quarterly(year 1) and annual follow up3
SEATTLE ANGINA QUESTIONNAIRE
The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100. A higher score means better control of chest pain, chest tightness, angina, or shortness of breath. Change from Baseline at each visits will be measure.
Time frame
Baseline, 6 week and annual follow up4
Duke Activity Status Inventory (DASI)
It is a self-administered questionnaire that measures a patient's functional capacity. Change from Baseline at each visit will be measure. Maximum response is a total of 16.7 while minimum is 0.
Time frame
Baseline, 6 week and annual follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cedars-Sinai Medical Center
Lead sponsor
University of Florida
Collaborator
Source ClinicalTrials.gov