Cardiac DiseaseNCT04338386
Detection and Pathogenesis of Novel Protein F
An observational study of Cardiac Disease and Multiple Myeloma, run by Wuhan Asia Heart Hospital.
Trial summary
From December 6, 2019 to March 23, 2020, the research group of Qingkun Fan found a novel protein(temporarily named protein F) in heparin anticoagulant plasma of three patients with heart disease. One patient was diagnosed with multiple myeloma.However, protein F cannot be detected by serum protein electrophoresis. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiac Disease, Multiple Myeloma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2020to 14 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with heart diesease
Who may be able to join
- Testing total protein and albumin
- Testing routine blood test
Who cannot join
- high triglycerides (TG>5.00 mmol/L)
- hyperbilirubinemia (TBIL>170 mmol/L)
- fat emulsion used in past 3 days
- patients with hemolytic disease
- pregnant and lactating women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
From December 6, 2019 to March 23, 2020, the research group of Qingkun Fan found a novel protein(temporarily named protein F) in heparin anticoagulant plasma of three patients with heart disease. One patient was diagnosed with multiple myeloma.However, protein F cannot be detected by serum protein electrophoresis. Preliminary studies have shown that this novel protein F have an obvious absorption peak at about 600nm. Placed at 2-8 degrees for 7 days, protein F will be isolated from heparin plasma. To the naked eye, protein F appear to be transparent jelly between the red blood cells and the plasma. The specific protein F, how it is produced, how it causes disease are still unknown. This study will explore how to detect protein F and how it is produced.
Read the detailed description
Protein F screening was performed on anticoagulant blood plasma with heparin Lithium or blood serum by in-house turbidimetric method in Automatic biochemical analyzer.
All patients were followed-up for 3 years by telephones, routine appointment out-patient clinic or returning visit.
- Conditions
- Cardiac Disease, Multiple Myeloma
- Keywords
- diagnosis, protein, cardiac disease, multiple myeloma, globulin
- Medical subject headings
- Heart Diseases, Multiple Myeloma, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of plasma protein F content
the protein F content was measured by turbidimetric assay in automatic biochemical analyzer
Measured: six month
Secondary outcomes (1)
Number of Participants with Multiple myeloma
Develop or be diagnosed with multiple myeloma
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start15 Apr 2020 (estimated)
- Primary completion14 Mar 2025 (estimated)
- Study completion14 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhenlu Zhang, MD，Ph,D, Study chair, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338386
- Sponsor's protocol ID
- YX-2020-B002
- Status last verified
- Apr 2020
- First submitted
- 4 Apr 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Pathogenesis of Novel Protein F
- ClinicalTrials.gov ID
- NCT04338386
- Acronym / sponsor ID
- YX-2020-B002
- Conditions
- Cardiac Disease, Multiple Myeloma
- Keywords
- diagnosis, protein, cardiac disease, multiple myeloma, globulin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 14 Mar 2025 (estimated)
- Study completion
- 14 Mar 2028 (estimated)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
From December 6, 2019 to March 23, 2020, the research group of Qingkun Fan found a novel protein(temporarily named protein F) in heparin anticoagulant plasma of three patients with heart disease. One patient was diagnosed with multiple myeloma.However, protein F cannot be detected by serum protein electrophoresis. Preliminary studies have shown that this novel protein F have an obvious absorption peak at about 600nm. Placed at 2-8 degrees for 7 days, protein F will be isolated from heparin plasma. To the naked eye, protein F appear to be transparent jelly between the red blood cells and the plasma. The specific protein F, how it is produced, how it causes disease are still unknown. This study will explore how to detect protein F and how it is produced.
Detailed description
Protein F screening was performed on anticoagulant blood plasma with heparin Lithium or blood serum by in-house turbidimetric method in Automatic biochemical analyzer.
All patients were followed-up for 3 years by telephones, routine appointment out-patient clinic or returning visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with heart diesease
Key inclusion criteria (2 listed)
- Testing total protein and albumin
- Testing routine blood test
Key exclusion criteria (5 listed)
- high triglycerides (TG>5.00 mmol/L)
- hyperbilirubinemia (TBIL>170 mmol/L)
- fat emulsion used in past 3 days
- patients with hemolytic disease
- pregnant and lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of plasma protein F content
Time frame: six month
the protein F content was measured by turbidimetric assay in automatic biochemical analyzer
1 secondary outcome
Number of Participants with Multiple myeloma
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhenlu Zhang, MD，Ph,D study chair
Wuhan Asia Heart Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease and Multiple Myeloma, run by Wuhan Asia Heart Hospital.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingkun Fan, MD (027-65796747, fqk@wahh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of plasma protein F content (time frame: six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Apr 2020.