Platelet Reactivity in Non-cardiac Inflammation A Prospective Observational Single Centre Study.

NCT05769894 | Unknown

• 1 other identifier: RHMCAR0622
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Non-cardiac acute and chronic inflammatory conditions are associated with high risk of acute myocardial infarction. Specifically, there are reports of high prevalence of AMI and cardiac death in chronic conditions such as Rheumatoid arthritis, chronic gum disease, psoriasis and Chronic airway disease. Furthermore, there are intriguing temporal links between acute non-cardiac conditions, including fractured neck of femur and admission for chest infection in the elderly and subsequent risk of AMI within the next few weeks. Finally, a more recent association has been reported between COVID vaccination and acute thrombotic events. In Summary, a link between acute non-cardiac inflammatory conditions and subsequent AMI in a near term envelope is established, but unexplained, and circumstantial evidence so far suggests a possible mechanism in terms of dynamic alteration in platelet reactivity. It is this concept we wish to explore further in the proposed set of experiments. Our experiments may provide some insight into a potential mechanism of such an association, which could have implications for future tailored therapeutic interventions. We will recruit 5 groups of patients, consistent with the data produced previously and the literature regarding disease models of non-cardiac inflammations. Aiming to recruit 20 patients per group with 100 candidates in total. Groups including:

1. 1.Fracture neck of femur.
2. 2.Patients \>70 years age admitted with chest infection.
3. 3.Healthy volunteers receiving fourth COVID booster vaccine.
4. 4.Patients admitted with AMI within 6 weeks of (fractured neck of femur, chest infection Rheumatoid arthritis flare up, exacerbation of psoriasis and exacerbation of inflammatory bowel disease).
5. 5.AMI secondary to stent thrombosis.

Conditions

Inflammatory Response; Platelet Aggregation, Spontaneous

Outcome Measures

Primary Outcomes (1)

• Dynamic platelet reactivity with non-cardiac inflammation

  Detecting an association between dynamic platelet reactivity and vascular inflammatory status in a variety of non-cardiac inflammatory conditions

  During the period of recruitment (Max 1 month for each patient)

Study Arms (5)

Fracture neck of femur

Trauma and Orthopaedics wards and the Emergency department will be screened for new admissions with fractured neck of femur proven by X-ray on admission, thereby identifying 20 participants according to eligibility criteria. Suitable patients will be approached about the study and given an information sheet. Later, when they have had enough time to consider, they will be enrolled if they are happy to provide written informed consent. Blood samples will be taken on the ward on admission, 24, 48 and 72 hours from admission and at 1 month. Blood will be collected in 4 tubes on each occasion. (1 x2ml 3.2% sodium citrate vacutainer, 1 x 6ml lithium heparin vacutainer. 2 x 5ml SST tubes for Inflammatory markers.) A detailed description of this is laid out below.

Other: No intervention given

Patients > 70 years age admitted with chest infection

The Emergency department, Acute Medical Unit and medical wards will be screened for eligible participants whose primary diagnosis is chest infection (Acute bronchitis or Pneumonia). Aiming to recruit 20 participants. Acute Bronchitis is a lower respiratory tract infection causing inflammation in the bronchial airways It is a clinical diagnosis characterised by a cough with no evidence of pneumonia. The chest X-ray can be normal. Pneumonia is an infection of the lung tissue in which the air sacs in the lungs become filled with microorganisms, fluid and inflammatory cells, affecting the function of the lungs. 39 Patients will be selected according to symptoms, clinical diagnosis +/- Chest X-ray findings (Pneumonia only).

Other: No intervention given

Healthy volunteers following COVID booster

Aiming to recruit 20 participants due to have a COVID vaccine at Southampton General Hospital. We are aiming to recruit 20 healthy volunteers meeting the criteria as per study eligibility.

Other: No intervention given

Patient admitted with AMI within 6 weeks of inflammatory condition

Screening will include patients admitted with Type 1 or Type 2 MI or myocardial injury, as defined by the 4th Universal Definition, if they are within 6 weeks of one of the inflammatory conditions listed above.40 Suitable patients will be approached about the study and given an information sheet.

Other: No intervention given

AMI secondary to stent thrombosis

Eligible patients will have been admitted with definite stent thrombosis according to the Academic Research Consortium definition. 41 Stent thrombosis is a complete occlusion of the artery secondary to thrombus inside the stent. ARC (Academic research consortium) has identified stent thrombosis detected by angiography as Definite stent thrombosis (ST). They also categorised stent thrombosis as early (up to 30 days from deployment), or late (30 days to 12 months from deployment). Suitable patients will be approached about the study and given an information sheet.

Other: No intervention given

Interventions

No intervention given OTHER

No intervention is planned. Blood samples will be taken at different stages.

AMI secondary to stent thrombosis; Fracture neck of femur; Healthy volunteers following COVID booster; Patient admitted with AMI within 6 weeks of inflammatory condition; Patients > 70 years age admitted with chest infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Thorough explanation was described previously in identifying study population.

You may qualify if:

• Patients over 18 years of age.
• Group 1 fractured neck of femur Group 2 age \>70yrs with chest infection Group 3 healthy volunteers receiving COVID booster dose Group 4 Acute myocardial infarction within 6 weeks from suffering (Fracture neck of femur, chest infection, rheumatoid arthritis flare-up, Psoriasis flare up or flare up of inflammatory bowel disease).
• Group 5 Acute myocardial infarction secondary to stent thrombosis.
• Written Informed Consent to participate in the study.
• Antiplatelet Naïve on admission, except for Groups 4 \& 5.

You may not qualify if:

• Surgery in an emergency setting.
• Liver failure. (From history and background, deranged Liver functions tests i.e AST/ALT)
• Renal failure requiring dialysis.
• Platelet count \<150,000.
• Medications including steroids, anticoagulants, non-steroidal anti-inflammatory drugs, COX-inhibitors.
• Known malignancy.
• Pregnancy.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

-Blood samples for inflammatory markers (CRP, IL-6, CD-40, TNF alpha)

MeSH Terms

Conditions

Platelet Aggregation, Spontaneous

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 15, 2023
• Study Start: April 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-03