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Coronary AtherosclerosisEndoGETNCT02313987

Endothelial Function-guided Therapy Compared to Usual Care in Patients With NOCAD

An observational study of Coronary Atherosclerosis, run by Itamar-Medical, Israel at 2 sites in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The current study is designed to test the hypothesis that compared to conventional treatment; endothelial function-guided treatment reduces adverse cardiovascular events in patients with non-obstructive coronary artery disease documented at clinically indicated coronary angiography. Read more about this study

Who is it for?
Ages 20 to 79 years
Conditions the study is for
Coronary Atherosclerosis
How many people
0 participants
Where
2 sitesIsrael
Study dates
Jun 2015to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects with chest pain and non-obstructive coronary artery disease (20-70% diameter luminal narrowing) will be enrolled in the study 2-30 days following the coronary angiograms

Who may be able to join

  • Subjects with chest pain and non-obstructive coronary artery disease documented by coronary angiography with 20-70% luminal diameter stenosis that does not justify coronary revascularization
  • Stable subjects without evidence of prior MI/CABG/PTCA.
  • Age 20 to 79 years
  • Ability to understand the study procedures and provide written informed consent
  • Willingness and ability to comply with the study and its scheduled visits and study procedures

Who cannot join

  • Age below 20 over 79 years
  • Subjects with documented MI, PTCA or CABG
  • Unstable angina
  • Any lesion > 20% luminal narrowing in the left main coronary artery
  • Congestive heart failure, NYHA class II - IV
  • Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR calculated by MDRD) < 20 mL/min/1.73m2 at screening
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  • Uncontrolled hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) , 1.0 time the lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, at screening
  • Symptomatic peripheral artery disease
  • History of drug or alcohol abuse
  • Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 times the ULN as determined by local laboratory analysis at screening
  • Prior CVA or TIA
  • Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ or stage 1 prostate carcinoma) with life expectancy of < 3 years
  • Any planned surgery within 3 months after randomization
  • Recipient of any major organ transplant (e.g., heart, lung, liver, bone marrow)
  • Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years
  • Known, concerning active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
  • Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s). Special clearance can be obtained from the Steering Committee for subjects enrolled in studies not conflicting with this protocol
  • History or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the subject to give written informed consent, would pose a risk to the subject safety, or interfere with the study evaluation, procedures or completion
  • Deformities of the digits of the upper extremities, which preclude adequate signal acquisition
  • Subjects under the effect of short-acting NTG (3 hours washout period)
  • Patient suffering from a medical condition prohibiting blood flow occlusion in both arms

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

  • Meir Hospital

    Kfar Saba

  • Tel Hashomer

    Ramat Gan, 52621

Other trials in Israel

About this study

Official title: The Impact of Endothelial Function-guided Therapy Compared to Usual Care on Major Adverse Cardiovascular Events in Patients With Chest Pain and Non-obstructive Coronary Artery Disease

The current study is designed to test the hypothesis that compared to conventional treatment; endothelial function-guided treatment reduces adverse cardiovascular events in patients with non-obstructive coronary artery disease documented at clinically indicated coronary angiography.

Read the detailed description

Subjects with chest pain and non-obstructive coronary artery disease (20-70% luminal diameter narrowing) documented by coronary angiograms will be enrolled in the study 2 - 30 days following the coronary angiograms. Only subjects who have signed an Informed Consent Form and meet all of the eligibility criteria will be qualified for enrollment.

Following the baseline EndoPAT testing subjects will be divided into two groups by their EndoPAT (EndoScore) results:

  1. Group A - normal EndoScore: Logarithmic value of RHI (Ln_RHI) >0.7
  2. Group B - abnormal EndoScore: Ln_RHI ≤ 0.7 The subjects of Group B will be randomized in 1:1 ratio (by envelopes with randomization numbers at each site) to Group B1 who will be treated conventionally i.e., "usual care" by the site study team; and Group B2 who will be treated with "enhanced care".

Staff prescribing treatment regime for subjects in group A and B1 ("usual care") along with the subjects in these groups, will be blinded to the EndoScore value.

Subjects of all groups will return for 4 follow-up visits: 180±14days, 360±14days, 720±14days and 1080±14days (study end).

Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02313987
Study groupRoleWhat they receive
A-Usual care- Standard care for NOCADSubjects with non obstructive CAD (20-70% luminal diameter stenosis) and normal Endothelial function as defined by EndoScore. These subjects will receive the standard care usually provided in each facility for patients with NOCAD
B1-Usual Care-Standard care for NOCADSubjects with non obstructive CAD (20-70% luminal diameter stenosis ) and abnormal Endothelial function as defined by EndoScore. These subjects will receive the standard care usually provided in each facility for patients with NOCAD. (Same care as Group A)
B2- Endothelial function guid careSubjects with non obstructive CAD and abnormal Endothelial function as defined by EndoScore. These subjects will receive the an Endothelial Function-guided Therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE

    Time to the first occurrence of death, cardiovascular death, non-fatal myocardial infarction, stroke, transient ischemic attack, coronary revascularization, or hospitalization for congestive heart failure.

    Measured: 3 years

Secondary outcomes (8)

  1. Rehospitalization for chest pain

    Measured: 3 years

  2. quality of life questionnaire

    Measured: 3years

  3. time to the first occurrence of cardiovascular death

    Measured: 3 years

  4. myocardial infarction

    Measured: 3 years

  5. Stroke

    Measured: 3 years

  6. time to the first occurrence of death from any cause

    Measured: 3 years

  7. hospitalization for worsening heart failure

    Measured: 3 years

  8. time to the first occurrence of ischemic fatal or non-fatal stroke or transient ischemic attack.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2014 (estimated)
  2. Study startJun 2015
  3. Primary completionJun 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Why it stopped: Study never began

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02313987
Sponsor's protocol ID
Endo-EndoGET-001
Acronym
EndoGET
Status last verified
Feb 2016
First submitted
8 Dec 2014
Last updated
24 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Atherosclerosis, run by Itamar-Medical, Israel at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02313987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.

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