Patients With Type 2 DM Who Underwent Coronary Angiography Due to Coronary Artery Disease and Presence of Microvascular Complications in Same PatientsNCT04975828
Correlation Between Micro Vascular Complications and Severity of Coronary Artery Disease in Type 2 DM
An observational study of Patients With Type 2 DM Who Underwent Coronary Angiography Due to Coronary Artery Disease and Presence of Microvascular Complications in Same Patients, run by Sohag University at 1 site in Egypt.
Trial summary
Diabetes is a major cause of morbidity and mortality worldwide and it contributes substantially to healthcare costs. Type 2 Diabetes mellitus is the most common type of diabetes accounting for approximately (90%) of all cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Type 2 DM Who Underwent Coronary Angiography Due to Coronary Artery Disease and Presence of Microvascular Complications in Same Patients
- What is being tested?
- albumin creatinine ratio -EGFR-fundus examination- coronary angiography.
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study enrolled 100 patients known type 2 DM with coronary artery disease and coronary angiography done to diagnosis coronary artery disease then assess microvascular complications in those patients by fundus examination-neurologic examination-albumin creatinine ratio-EGFR. IN STUDY investigator exclude any other cause can lead to microvascular complications example hypertension. aim of study to early predict coronary artery disease in patient with type 2 DM if microvascular complication presenet by non invasive investigation as stress ECG.
Who may be able to join
- 100 Cases were selected with type II (DM) patients who had been admitted for coronary angiography because of suspected (CAD) to the Catheter lab unit of Sohag University Hospital.
Who cannot join
- Type 1 DM.
- Smoker.
- Hypertension.
- Pregnant women.
- Patient known non diabetic retinal disease non diabetic. nephropathy or neuropathy.
- History of familial dyslipidemia.
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes is a major cause of morbidity and mortality worldwide and it contributes substantially to healthcare costs. Type 2 Diabetes mellitus is the most common type of diabetes accounting for approximately (90%) of all cases.
Type 2 DM carries a two to six times risk of death from cardiovascular etiologies, such that age adjusted prevalence of white Americans for coronary artery disease (CAD) is double in those with type 2 DM than those without .
- Being tested
- albumin creatinine ratio -EGFR-fundus examination- coronary angiography.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
albumin creatinine ratio -EGFR-fundus examination- coronary angiography.Diagnostic test
albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination.
| Study group | Role | What they receive |
|---|---|---|
| patients type 2 DM with coronary artery disease and diabetic retinopathy. | Not described Receives: Diagnostic Test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography. | |
| patients type 2 DM with coronary artery disease and diabetic neuropathy. | Not described Receives: Diagnostic Test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography. | |
| patients type 2 DM with coronary artery disease and diabetic nephropathy | Not described Receives: Diagnostic Test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography. | |
| patient type 2 DM with coronary artery disease and non microvascular complications. | Not described Receives: Diagnostic Test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography. |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between microvascular complications and severity of coronary disease in type2 DM.
outcome of study to assess correlation between coronary artery disease and microvascular complications in type 2 DM to early predict coronary artery disease in patient type 2 DM with microvascular complications by non invasive methods as stress ECG or CT coronary angio or cardiac MRI and prevent serious complications as myocardial infarction.
assess microvascular complication as follow albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start1 Jun 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Patients With Type 2 DM Who Underwent Coronary Angiography Due to Coronary Artery Disease and Presence of Microvascular Complications in Same PatientsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Khaled Fathy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975828
- Sponsor's protocol ID
- Soh-Med-21-07-02
- Status last verified
- Feb 2022
- First submitted
- 14 Jul 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ybarra-Munoz J, Jurado-Campos J, Garcia-Gil M, Zabaleta-Del-Olmo E, Mir-Coll T, Zabalegui A, Vidal J, Romeo JH. Cardiovascular disease predicts diabetic peripheral polyneuropathy in subjects with type 2 diabetes: A 10-year prospective study. Eur J Cardiovasc Nurs. 2016 Jun;15(4):248-54. doi: 10.1177/1474515114565215. Epub 2014 Dec 19.
PubMed 25527522Dal Canto E, Ceriello A, Ryden L, Ferrini M, Hansen TB, Schnell O, Standl E, Beulens JW. Diabetes as a cardiovascular risk factor: An overview of global trends of macro and micro vascular complications. Eur J Prev Cardiol. 2019 Dec;26(2_suppl):25-32. doi: 10.1177/2047487319878371. Epub 2019 Nov 13.
PubMed 31722562Glovaci D, Fan W, Wong ND. Epidemiology of Diabetes Mellitus and Cardiovascular Disease. Curr Cardiol Rep. 2019 Mar 4;21(4):21. doi: 10.1007/s11886-019-1107-y.
PubMed 30828746
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Micro Vascular Complications and Severity of Coronary Artery Disease in Type 2 DM
- ClinicalTrials.gov ID
- NCT04975828
- Acronym / sponsor ID
- Soh-Med-21-07-02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 23 Jul 2021 (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.
Diabetes is a major cause of morbidity and mortality worldwide and it contributes substantially to healthcare costs. Type 2 Diabetes mellitus is the most common type of diabetes accounting for approximately (90%) of all cases.
Type 2 DM carries a two to six times risk of death from cardiovascular etiologies, such that age adjusted prevalence of white Americans for coronary artery disease (CAD) is double in those with type 2 DM than those without .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients type 2 DM with coronary artery disease and diabetic retinopathy. | – | Diagnostic Test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography. |
| patients type 2 DM with coronary artery disease and diabetic neuropathy. | – | Diagnostic Test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography. |
| patients type 2 DM with coronary artery disease and diabetic nephropathy | – | Diagnostic Test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography. |
| patient type 2 DM with coronary artery disease and non microvascular complications. | – | Diagnostic Test: albumin creatinine ratio -EGFR-fundus examination- coronary angiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolled 100 patients known type 2 DM with coronary artery disease and coronary angiography done to diagnosis coronary artery disease then assess microvascular complications in those patients by fundus examination-neurologic examination-albumin creatinine ratio-EGFR. IN STUDY investigator exclude any other cause can lead to microvascular complications example hypertension. aim of study to early predict coronary artery disease in patient with type 2 DM if microvascular complication presenet by non invasive investigation as stress ECG.
Key inclusion criteria (1 listed)
- 100 Cases were selected with type II (DM) patients who had been admitted for coronary angiography because of suspected (CAD) to the Catheter lab unit of Sohag University Hospital.
Key exclusion criteria (6 listed)
- Type 1 DM.
- Smoker.
- Hypertension.
- Pregnant women.
- Patient known non diabetic retinal disease non diabetic. nephropathy or neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| albumin creatinine ratio -EGFR-fundus examination- coronary angiography.albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination. | Diagnostic test | patient type 2 DM with coronary artery disease and non microvascular complications., patients type 2 DM with coronary artery disease and diabetic nephropathy, patients type 2 DM with coronary artery disease and diabetic neuropathy., patients type 2 DM with coronary artery disease and diabetic retinopathy. |
Primary outcome
correlation between microvascular complications and severity of coronary disease in type2 DM.
Time frame: 4 months
outcome of study to assess correlation between coronary artery disease and microvascular complications in type 2 DM to early predict coronary artery disease in patient type 2 DM with microvascular complications by non invasive methods as stress ECG or CT coronary angio or cardiac MRI and prevent serious complications as myocardial infarction. assess microvascular complication as follow albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Background: PubMed 25527522Ybarra-Munoz J, Jurado-Campos J, Garcia-Gil M, Zabaleta-Del-Olmo E, Mir-Coll T, Zabalegui A, Vidal J, Romeo JH. Cardiovascular disease predicts diabetic peripheral polyneuropathy in subjects with type 2 diabetes: A 10-year prospective study. Eur J Cardiovasc Nurs. 2016 Jun;15(4):248-54. doi: 10.1177/1474515114565215. Epub 2014 Dec 19.
- Background: PubMed 31722562Dal Canto E, Ceriello A, Ryden L, Ferrini M, Hansen TB, Schnell O, Standl E, Beulens JW. Diabetes as a cardiovascular risk factor: An overview of global trends of macro and micro vascular complications. Eur J Prev Cardiol. 2019 Dec;26(2_suppl):25-32. doi: 10.1177/2047487319878371. Epub 2019 Nov 13.
- Background: PubMed 30828746Glovaci D, Fan W, Wong ND. Epidemiology of Diabetes Mellitus and Cardiovascular Disease. Curr Cardiol Rep. 2019 Mar 4;21(4):21. doi: 10.1007/s11886-019-1107-y.
- Individual participant dataSharing planned: Yes
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Type 2 DM Who Underwent Coronary Angiography Due to Coronary Artery Disease and Presence of Microvascular Complications in Same Patients, run by Sohag University at 1 site in Egypt.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
correlation between microvascular complications and severity of coronary disease in type2 DM. (time frame: 4 months). 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 NCT04975828, which also lists 3 linked publications.
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 16 Feb 2022.