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NCT02582021 · ClinicalTrials.gov registry record
WISE CVD - Continuation (WISE HFpEF)
A clinical trial of Cardiovascular Disease and Microvascular Coronary Dysfunction, sponsored by Cedars-Sinai Medical Center.
- Recruiting
- Registry status
- 220
- Enrollment target
- 1
- Study location
NCT02582021 is a study of Cardiovascular Disease and Microvascular Coronary Dysfunction that is actively recruiting participants, run by Cedars-Sinai Medical Center. The registered enrollment target is 220 participants, below the 2,712-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02582021, a study of Cardiovascular Disease and Microvascular Coronary Dysfunction, is actively recruiting participants, sponsored by Cedars-Sinai Medical Center.
- RECRUITING
- Registry status
- 220 participants
- Enrollment target
- 1
- Study location
Study Summary
The Women's Ischemia Study Evaluation (WISE), a cohort study of over 1000 women, has made many contributions to the understanding of cardiovascular disease. A milestone acknowledged in the 2011 AHA Herrick Lecture is the role of Coronary Microvascular Dysfunction (CMD) in women with symptoms/signs of ischemia without obstructive coronary artery disease (CAD). While in 1996, CMD was considered "an imaging artifact", in 2013, it is a widely accepted as a pathophysiologic process requiring systematic cohesive scientific pursuit. CMD is prevalent, associated with adverse clinical outcomes, poor quality of life and healthcare costs rivaling obstructive CAD. There are 2-3 million US women with CMD, and 100,000 new cases projected annually placing CMD prevalence, morbidity and costs higher than all female reproductive cancers combined. Among women with ischemia, preserved ejection fraction and no obstructive CAD, it has been observed that there are relatively more new onset heart failure (HF) hospitalizations than nonfatal myocardial infarction (MI). It has been hypothesized that CMD contributes to left ventricular (LV) diastolic dysfunction and subsequent heart failure with preserved ejection fraction (HFpEF). Preliminary data further suggests that left ventricular diastolic dysfunction is linked to CMD via a mechanism of augmentation and/or perpetuation by cardiomyocyte fat accumulation. HFpEF is prevalent in women and older men, but poorly understood. Mechanistic understanding is critical to HFpEF intervention and guideline development. The study hypotheses are as follows: 1. Risk factor conditions (hypertension, dyslipidemia, dysglycemia, loss of estrogen) promote an inflammatory and pro-oxidative state making the microvasculature vulnerable; 2. Vulnerable coronary microvasculature becomes dysregulated (sympathetic nervous system activation, endothelial dysfunction, changes in vascular smooth muscle activation, spasm) causing repeated episodes of transient ischemia;
Conditions Studied
Interventions
- PROCEDURE Coronary Angiography
- PROCEDURE Coronary Reactivity Testing
- PROCEDURE Cardiac Magnetic Resonance Imaging
- PROCEDURE Cardiac Magnetic Resonance Angiography
- PROCEDURE Computed Coronary Tomographic Angiography
Study Locations (1)
California
- Cedars-Sinai Women's Heart Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2015-11 |
| Est. Completion | 2030-02 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02582021
The ClinicalTrials.gov registry entry for NCT02582021 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,712-participant average among 136 other Cardiovascular Disease trials with a reported enrollment target (92% lower). The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 5 interventions - of which Coronary Angiography is the first listed.
NCT02582021 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02582021 about?
NCT02582021 is a clinical study titled "WISE CVD - Continuation (WISE HFpEF)". The Women's Ischemia Study Evaluation (WISE), a cohort study of over 1000 women, has made many contributions to the understanding of cardiovascular disease. A milestone acknowledged in the 2011 AHA Herrick Lecture is the role of Coronary Microvascular Dysfunction (CMD) in women with symptoms/signs o...
What is the current status of trial NCT02582021?
This trial is currently recruiting. The enrollment target is 220 participants. The study started on 2015-11. Estimated completion is 2030-02.
What conditions does trial NCT02582021 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Microvascular Coronary Dysfunction.
What interventions are being tested in trial NCT02582021?
The interventions under investigation include: Coronary Angiography (PROCEDURE), Coronary Reactivity Testing (PROCEDURE), Cardiac Magnetic Resonance Imaging (PROCEDURE), Cardiac Magnetic Resonance Angiography (PROCEDURE), Computed Coronary Tomographic Angiography (PROCEDURE).
Who is sponsoring clinical trial NCT02582021?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02582021 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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