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NCT00600106 · ClinicalTrials.gov registry record · NA
Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study
A NA study of Myocardial Ischemia, sponsored by Cedars-Sinai Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT00600106: Completed NA study of Myocardial Ischemia, sponsored by Cedars-Sinai Medical Center.
NCT00600106 is a NA study of Myocardial Ischemia that has completed, run by Cedars-Sinai Medical Center. The registered enrollment target is 37 participants, below the 2,137-participant average among 29 other Myocardial Ischemia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00600106, a NA study of Myocardial Ischemia, has completed, sponsored by Cedars-Sinai Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript. The main trial duration: December 1999 - May 2003. The ancillary data analysis project duration: April 2006 - March 2010.
Primary Outcome
Inducible myocardial ischemia measured by P-31 gated magnetic resonance cardiac spectroscopy (MRS) is reported as change (∆) in PCr/ATP ratio, with isometric submaximal handgrip stress. PCr/ATP ratio defined as (stress-\[average of rest and recovery periods\]) / average of rest and recover periods X 100, and expressed as % mean ± SD. For this trial, myocardial ischemia was pre-specified as a fall in quantitative PCR/ATP ratio \>20% from rest, and a lower value is considered indicative of greater
Conditions Studied
Interventions
- DRUG Placebo
- DRUG 1/10 NA/EE
Study Locations (1)
California
- Cedars-Sinai Women's Heart Center, 8631 W. 3rd St, Suite 740 - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 1999-12 |
| Est. Completion | 2010-03 |
| Phase | NA |
What the finished NCT00600106 record still lists
NCT00600106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 2,137-participant average among 29 other Myocardial Ischemia trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Myocardial Ischemia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00600106 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00600106 about?
NCT00600106 is a clinical study titled "Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study". The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinat...
What is the current status of trial NCT00600106?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 1999-12. Estimated completion is 2010-03.
What conditions does trial NCT00600106 study?
This clinical trial studies the following conditions: Myocardial Ischemia.
What interventions are being tested in trial NCT00600106?
The interventions under investigation include: Placebo (DRUG), 1/10 NA/EE (DRUG).
Who is sponsoring clinical trial NCT00600106?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00600106 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00600106's enrollment target sits among peer trials
37 27th of 29 higher than 3 of 29 other Myocardial Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myocardial Ischemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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